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| ID | Type | Description | Link |
|---|---|---|---|
| 11-3429 | Other Identifier | FDA Orphan Designation Request |
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The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in participants with known or suspected focal liver lesions and severe renal impairment. Study treatment is a single oral dose of Mangoral (800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3). Adult male and female participants with severe renal impairment or acute kidney injury and who are being evaluated for known or suspected focal liver lesions will be included. Primary diagnostic efficacy in terms of visualization of detected lesions will be evaluated centrally by 3 independent readers. Study MRIs will also be evaluated by the on-site radiologists for the assessment of secondary objectives and for clinical purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mangoral | Experimental | All participants will receive a single dose of Mangoral (800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mangoral | Drug | 800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Co-primary Endpoint: Lesion Border Delineation in Combined MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by 2 co-primary variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion border delineation from 1 (poor: lesion border is poorly distinct) to 4 (excellent: lesion border is sharply and clearly distinct). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
| Co-primary Endpoint: Lesion Contrast in Combined MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by 2 co-primary variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion contrast from 1 (poor: difference in signal intensity between the lesion and the surrounding normal liver tissue is poor) to 4 (excellent: difference in signal intensity between the lesion and the surrounding liver is marked). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions Detected by Each MRI Method | Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for detection of lesions were undertaken by on-site readers (assessing participants at their own site) and during central reading sessions by 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Hamm, MD | Charite Berlin, Dept. of Radiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Arizona | Scottsdale | Arizona | 85259 | United States | ||
| University of California at Los Angeles Ronald Reagan Medical Center |
The study consisted of:
A total of 87 participants were enrolled in 32 study sites in Europe, Asia, North America, and South America between February 2020 and February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mangoral | All participants received a single oral dose of mangoral (800 mg manganese [II] chloride tetrahydrate [MnCl2 4H2O]). Mangoral is a novel manganese-based contrast agent for liver MRI. Unenhanced MRI of the liver was performed during the Baseline Period, i.e., either on the day prior to the mangoral-enhanced MRI or predose on the same day as the mangoral-enhanced MRI. Mangoral-enhanced MRI of the liver was performed 4 (±1) hours after investigational medicinal product (IMP) administration. Each unenhanced and each mangoral-enhanced liver MRI examination will consist of axial T1- and T2-weighted image sequences and a diffusion-weighted imaging (DWI) sequence. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2021 | Nov 27, 2024 |
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Multicenter, open-label, pivotal phase III study
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| Lesion Border Delineation in Mangoral-enhanced MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion border delineation from 1 (poor: lesion border is poorly distinct) to 4 (excellent: lesion border is sharply and clearly distinct). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Lesion Contrast in Mangoral-enhanced MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion contrast from 1 (poor: difference in signal intensity between the lesion and the surrounding normal liver tissue is poor) to 4 (excellent: difference in signal intensity between the lesion and the surrounding liver is marked). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Confidence in Lesion Detection Score | Each lesion was evaluated on a 3-point scale: 1 (lesion is detected with low confidence), 2 (lesion is detected with moderate confidence), 3 (lesion is detected with high confidence). Higher confidence in lesion detection scores represent better outcomes. Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion detection were undertaken by on-site readers (assessing participants are their own site) and during central reading sessions by 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
| Confidence in Lesion Localization Score | Each lesion was evaluated on a 3-point scale: 1 (lesion is localized to a liver segment with low confidence), 2 (lesion is localized to a liver segment with moderate confidence), 3 (lesion is localized to a liver segment with high confidence). Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion localization were undertaken by on-site readers (assessing participants at their own site) and during central reading sessions by 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
| Longest Diameter of Largest and Smallest Lesion | Assessments of unenhanced MRI and mangoral-enhanced MRI for lesion dimensions were undertaken during central reading sessions by 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Percentage Liver Signal Intensity (SI) Enhancement in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. SI liver was defined as the SI of the liver. Liver SI enhancement (%) = ([SI liver post contrast - SI liver pre contrast] / [SI liver pre contrast]) × 100. Assessments of unenhanced MRI and mangoral-enhanced MRI for liver SI were undertaken during central reading sessions by the 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Liver-to-lesion Contrast (LLC) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. Up to 5 lesions per participant of ≥ 2 cm in diameter were evaluated and these lesions were the same on pre-and post-contrast images. SI lesion was defined as the SI of these lesions. SI liver was defined as the SI of the liver. LLC = (SI liver - SI lesion) / (SI liver + SI lesion). Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for LLC ratio were undertaken during central reading sessions by the 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Signal-to-noise Ratio (SNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. SI liver was defined as the SI of the liver. Standard deviation of the background noise was measured using the largest possible rectangular region of interest vertical to the patient's abdomen in the direction of the phase-encoding gradient. SNR = SI liver / standard deviation noise. Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for SNR were undertaken during central reading sessions by the 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Contrast-to-noise Ratio (CNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. Up to 5 lesions per participant of ≥ 2 cm in diameter were evaluated and these lesions were the same on pre-and post-contrast images. SI lesion was defined as the SI of these lesions. SI liver was defined as the SI of the liver. Standard deviation of the background noise was measured using the largest possible rectangular region of interest vertical to the patient's abdomen in the direction of the phase-encoding gradient. CNR = (SI liver - mean of SI lesion) / standard deviation noise. Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for CNR were undertaken during central reading sessions by the 3 independent, blinded readers. | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
| Number of Participants With Change(s) in Recommended Management Based on Diagnostic Performance of Combined MRI or Mangoral-enhanced MRI Compared to Unenhanced MRI | A participant was considered to have a change in recommended management when compared to unenhanced MRI if recommended management was different following assessment of the combined MRI or mangoral-enhanced MRI, including next steps in management (i.e. chemotherapy, surgery, local ablation procedure, combination therapy, or other [specify]). Recommended patient management from "other" in unenhanced MRI to "other" in combined MRI or mangoral-enhanced MRI was considered not a change regardless of the free text. Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion detection were undertaken by on-site readers (assessing participants at their own site with access to patient records) and during central reading sessions by 3 independent, blinded readers (without access to patient records). | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| Saint Louis University | St Louis | Missouri | 63103 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| PanAmerican Clinical Research LLC | Brownsville | Texas | 78521 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Fundación Intecnus | Bariloche | Río Negro Province | R8405AZA | Argentina |
| Centro Rossi Body Imaging | Buenos Aires | C1425 BEE | Argentina |
| Sanatorio Allende Nueva Córdoba | Córdoba | X5000JHQ | Argentina |
| Hospital Pablo Tobon Uribe | Medellín | Antioquia | 69-240 | Colombia |
| Clínica Universitaria Colombia | Bogotá | Cundinamarca | 111221 | Colombia |
| Sociedad de Cirugía de Bogotá - Hospital de San José | Bogotá | Cundinamarca | 111611 | Colombia |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie | Frankfurt | 60590 | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie | Karlsruhe | 76227 | Germany |
| Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie | Kiel | 24105 | Germany |
| Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus | Munich | 81377 | Germany |
| Institut für Röntgendiagnostik | Regensburg | 93053 | Germany |
| Azienda Socio Sanitaria Territoriale (ASST) | Milan | Lombardy | 20157 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| Ospedale del Mare | Naples | 80147 | Italy |
| Istituto Nazionale Tumori IRCCS Fondazione G. Pascale | Naples | Italy |
| Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | 00161 | Italy |
| Ospedale di Belcolle | Viterbo | 01100 | Italy |
| Panamerican Clinical Research - Cuernavaca Rio Mayo | Cuernavaca | 62290 | Mexico |
| Panamerican Clinical Research Mexico | Guadalajara | 44670 | Mexico |
| Panamerican Clinical Research - Querétaro Avenida Paseo de la República | Querétaro | 76230 | Mexico |
| Szpital Uniwersytecki nr 1 im. Dr A. Jurasza, Wydział Katedra i Zakład Radiologii i Diagnostyki Obrazowej | Bydgoszcz | Poland |
| Szpital Uniwersytecki w Krakowie Zakład Diagnostyki Obrazowej CUMRiK Ul | Krakow | 31-501 | Poland |
| EuroMedis Sp. z o.o. | Szczecin | 70-111 | Poland |
| Altay Regional Oncology Dispencery | Barnaul | Zmeigorsky trakt 110 | Russia |
| State Institution of Healthcare "Regional Oncology Dispensary" | Irkutsk | 664035 | Russia |
| Scientific and Research Institute of Oncology named after N.N. Blokhin | Moscow | 115478 | Russia |
| A.V. Vishnevsky Institute of Surgery | Moscow | 117997 | Russia |
| National Medical Research Radiology Center Named After Herzen | Moscow | 125284 | Russia |
| JSC "Avicenna" | Novosibirsk | 630099 | Russia |
| State Institution of Healthcare of Omsk region | Omsk | 644013 | Russia |
| SBIH of Pskov Regional Clinical Oncologic Dispensary | Pskov | 180004 | Russia |
| LLC "Clinica YZI 4D" | Pyatigorsk | 357500 | Russia |
| N.N. Petrov Research Institute of Oncology | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg State Budgetary Healthcare Institution | Saint Petersburg | 198255 | Russia |
| Smolensk Clinical Hospital | Smolensk | 214006 | Russia |
| State Autonomous Healthcare Institution of the Tyumen Region | Tyumen | 625033 | Russia |
| Karolinska University Hospital Huddinge | Stockholm | Sweden |
| Ege University Medical Faculty Hospital | Bornova | İzmir | 35100 | Turkey (Türkiye) |
| Erciyes University Medical Faculty Hospital | Melikgazi | Kayseri | 38030 | Turkey (Türkiye) |
| Kocaeli University | İzmit | Kocaeli | 41001 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty Hospital | Ankara | 06230 | Turkey (Türkiye) |
| İstanbul Üniversitesi - Istanbul Tıp Fakültesi | Istanbul | 34093 | Turkey (Türkiye) |
| Underwent Unenhanced MRI |
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| Underwent Mangoral-enhanced MRI |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population: All participants enrolled in the study (fulfil all inclusion criteria, but none of the exclusion criteria and have been included in the clinical study at Visit 2).
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| ID | Title | Description |
|---|---|---|
| BG000 | Mangoral | All participants received a single oral dose of mangoral (800 mg). Mangoral is a novel manganese-based contrast agent for liver MRI. Unenhanced MRI of the liver was performed during the Baseline Period, i.e., either on the day prior to the mangoral-enhanced MRI or predose on the same day as the mangoral-enhanced MRI. Mangoral-enhanced MRI of the liver was performed 4 (±1) hours after IMP administration. Each unenhanced and each mangoral-enhanced liver MRI examination will consist of axial T1- and T2-weighted image sequences and a DWI sequence. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Co-primary Endpoint: Lesion Border Delineation in Combined MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by 2 co-primary variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion border delineation from 1 (poor: lesion border is poorly distinct) to 4 (excellent: lesion border is sharply and clearly distinct). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | Full Analysis Set (FAS): All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
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| Primary | Co-primary Endpoint: Lesion Contrast in Combined MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by 2 co-primary variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion contrast from 1 (poor: difference in signal intensity between the lesion and the surrounding normal liver tissue is poor) to 4 (excellent: difference in signal intensity between the lesion and the surrounding liver is marked). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
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| Secondary | Number of Lesions Detected by Each MRI Method | Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for detection of lesions were undertaken by on-site readers (assessing participants at their own site) and during central reading sessions by 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. | Posted | Mean | Standard Deviation | lesions | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
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| Secondary | Lesion Border Delineation in Mangoral-enhanced MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion border delineation from 1 (poor: lesion border is poorly distinct) to 4 (excellent: lesion border is sharply and clearly distinct). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Lesion Contrast in Mangoral-enhanced MRI Compared to Unenhanced MRI | Visualization of focal liver lesions was measured by variables: 'lesion border delineation' and 'lesion contrast' compared to liver background. Qualitative assessment determined on the 4-point scales for up to 15 lesions per participant. Each lesion was assessed for lesion contrast from 1 (poor: difference in signal intensity between the lesion and the surrounding normal liver tissue is poor) to 4 (excellent: difference in signal intensity between the lesion and the surrounding liver is marked). Central reading sessions were undertaken by 3 independent, blinded readers. The scores were calculated for each participant by summing the individual lesion scores and calculating the mean. The total score could range from 1 to 4 for each participant with higher scores representing a better outcome. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Confidence in Lesion Detection Score | Each lesion was evaluated on a 3-point scale: 1 (lesion is detected with low confidence), 2 (lesion is detected with moderate confidence), 3 (lesion is detected with high confidence). Higher confidence in lesion detection scores represent better outcomes. Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion detection were undertaken by on-site readers (assessing participants are their own site) and during central reading sessions by 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The number of participants analyzed represents the number of participants with analyzed MRI images. Independent readers analyzed a maximum of 15 lesions per participant. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 | Lesions | Lesions |
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| Secondary | Confidence in Lesion Localization Score | Each lesion was evaluated on a 3-point scale: 1 (lesion is localized to a liver segment with low confidence), 2 (lesion is localized to a liver segment with moderate confidence), 3 (lesion is localized to a liver segment with high confidence). Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion localization were undertaken by on-site readers (assessing participants at their own site) and during central reading sessions by 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The number of participants analyzed represents the number of participants with analyzed MRI images. Independent readers analyzed a maximum of 15 lesions per participant. | Posted | Mean | Standard Deviation | score on a scale | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 | Lesions | Lesions |
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| Secondary | Longest Diameter of Largest and Smallest Lesion | Assessments of unenhanced MRI and mangoral-enhanced MRI for lesion dimensions were undertaken during central reading sessions by 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with detected and scored lesions by each reader. | Posted | Mean | Standard Deviation | mm | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Percentage Liver Signal Intensity (SI) Enhancement in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. SI liver was defined as the SI of the liver. Liver SI enhancement (%) = ([SI liver post contrast - SI liver pre contrast] / [SI liver pre contrast]) × 100. Assessments of unenhanced MRI and mangoral-enhanced MRI for liver SI were undertaken during central reading sessions by the 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. As pre-specified in the statistical analysis plan, results are presented for SI enhancement following mangoral-enhanced MRI compared to unenhanced MRI. | Posted | Mean | Standard Deviation | Percentage SI enhancement | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Liver-to-lesion Contrast (LLC) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. Up to 5 lesions per participant of ≥ 2 cm in diameter were evaluated and these lesions were the same on pre-and post-contrast images. SI lesion was defined as the SI of these lesions. SI liver was defined as the SI of the liver. LLC = (SI liver - SI lesion) / (SI liver + SI lesion). Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for LLC ratio were undertaken during central reading sessions by the 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | ratio | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Signal-to-noise Ratio (SNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. SI liver was defined as the SI of the liver. Standard deviation of the background noise was measured using the largest possible rectangular region of interest vertical to the patient's abdomen in the direction of the phase-encoding gradient. SNR = SI liver / standard deviation noise. Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for SNR were undertaken during central reading sessions by the 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | ratio | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Contrast-to-noise Ratio (CNR) in Mangoral-enhanced MRI Compared to Unenhanced MRI | Quantitative SI was measured by positioning circular regions of interest in a homogenous area in the liver and the assessed liver lesion on the same image. Up to 5 lesions per participant of ≥ 2 cm in diameter were evaluated and these lesions were the same on pre-and post-contrast images. SI lesion was defined as the SI of these lesions. SI liver was defined as the SI of the liver. Standard deviation of the background noise was measured using the largest possible rectangular region of interest vertical to the patient's abdomen in the direction of the phase-encoding gradient. CNR = (SI liver - mean of SI lesion) / standard deviation noise. Higher ratio scores represent a better outcome. Assessments of unenhanced MRI and mangoral-enhanced MRI for CNR were undertaken during central reading sessions by the 3 independent, blinded readers. | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. The overall number of participants analyzed includes all participants that contributed data for the outcome measure. The number of participants analyzed per row includes only participants with matched lesions (detected and scored on both unenhanced MRI and combined MRI) by each reader. | Posted | Mean | Standard Deviation | ratio | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0 |
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| Secondary | Number of Participants With Change(s) in Recommended Management Based on Diagnostic Performance of Combined MRI or Mangoral-enhanced MRI Compared to Unenhanced MRI | A participant was considered to have a change in recommended management when compared to unenhanced MRI if recommended management was different following assessment of the combined MRI or mangoral-enhanced MRI, including next steps in management (i.e. chemotherapy, surgery, local ablation procedure, combination therapy, or other [specify]). Recommended patient management from "other" in unenhanced MRI to "other" in combined MRI or mangoral-enhanced MRI was considered not a change regardless of the free text. Assessments of unenhanced MRI, mangoral-enhanced MRI, and combined MRI for confidence in lesion detection were undertaken by on-site readers (assessing participants at their own site with access to patient records) and during central reading sessions by 3 independent, blinded readers (without access to patient records). | FAS: All participants of the Safety Population who received the IMP and for whom the primary efficacy variable was assessable, i.e. all unenhanced / enhanced liver MRI images are assessable. As pre-specified in the statistical analysis plan, results are presented for change in recommended management following combined MRI and mangoral-enhanced MRI only. | Posted | Count of Participants | Participants | Unenhanced MRI: Baseline Period (Day -1 to Day 0); mangoral-enhanced MRI: 4 hours after mangoral administration on Day 0; and combined MRI: Baseline Period (Day -1 to Day 0) and 4 hours after mangoral administration on Day 0 |
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Up to Day 7
Safety Population: All participants enrolled in the study (fulfil all inclusion criteria, but none of the exclusion criteria and have been included in the clinical study at Visit 2).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mangoral | All participants received a single oral dose of mangoral (800 mg). Mangoral is a novel manganese-based contrast agent for liver MRI. Unenhanced MRI of the liver was performed during the Baseline Period, i.e., either on the day prior to the mangoral-enhanced MRI or predose on the same day as the mangoral-enhanced MRI. Mangoral-enhanced MRI of the liver was performed 4 (±1) hours after IMP administration. Each unenhanced and each mangoral-enhanced liver MRI examination will consist of axial T1- and T2-weighted image sequences and a DWI sequence. | 1 | 87 | 2 | 87 | 41 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood magnesium decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood creatine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Blood pressure systolic increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Breath sounds abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA (25.0) | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (25.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
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| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andreas Norlin | Ascelia Pharma AB | +46 735179119 | an@ascelia.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2023 | Nov 27, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C504368 | CMC-001 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Other |
|
| Unknown or Not Reported |
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| Reader 2 |
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| Reader 3 |
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| Paired difference of combined MRI versus unenhanced MRI: Reader 2 | t-test, 1 sided | p-values show a one-sided t-test with a significance level of 0.025. | <0.001 | Mean Difference (Final Values) | 0.80 | Standard Deviation | 0.892 | 2-Sided | 95 | 0.552 | 1.043 | Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome. | Superiority | Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study. |
| Paired difference of combined MRI versus unenhanced MRI: Reader 3 | t-test, 1 sided | p-values show a one-sided t-test with a significance level of 0.025. | <0.001 | Mean Difference (Final Values) | 0.65 | Standard Deviation | 0.622 | 2-Sided | 95 | 0.494 | 0.813 | Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome. | Superiority | Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study. |
| OG001 | Combined MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver (paired with unenhanced MRI; combined MRI) 4 [±1] hours after mangoral administration. Combined MRI was defined as the paired, simultaneous reading of both unenhanced and mangoral-enhanced MRIs. |
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| OG002 | Combined MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver (paired with unenhanced MRI; combined MRI) 4 [±1] hours after mangoral administration. Combined MRI was defined as the paired, simultaneous reading of both unenhanced and mangoral-enhanced MRIs. |
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| OG001 | Mangoral-enhanced MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
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| OG001 | Mangoral-enhanced MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
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All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
| OG002 | Combined MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver (paired with unenhanced MRI; combined MRI) 4 [±1] hours after mangoral administration. Combined MRI was defined as the paired, simultaneous reading of both unenhanced and mangoral-enhanced MRIs. |
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All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
| OG002 | Combined MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver (paired with unenhanced MRI; combined MRI) 4 [±1] hours after mangoral administration. Combined MRI was defined as the paired, simultaneous reading of both unenhanced and mangoral-enhanced MRIs. |
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| OG001 | Mangoral-enhanced MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
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| OG001 | Mangoral-enhanced MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
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| OG001 | Mangoral-enhanced MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver 4 [±1] hours after mangoral administration. Mangoral-enhanced MRI was defined as the reading of the mangoral enhanced MRI only. |
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| OG001 | Combined MRI | All participants undertook an unenhanced MRI examination of the liver during the Baseline Period (Day -1 to Day 0, i.e., within 24 hours of mangoral administration). On the day of MRI (Day 0), all participants received a single oral dose of mangoral (800 mg) after a fast of at least 4 hours and undertook a mangoral-enhanced MRI examination of the liver (paired with unenhanced MRI; combined MRI) 4 [±1] hours after mangoral administration. Combined MRI was defined as the paired, simultaneous reading of both unenhanced and mangoral-enhanced MRIs. |
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