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The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.
This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.
This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gadopiclenol-enhanced MRI then gadobutrol-enhanced MRI | Experimental | Cross-over design: each patient receives gadopiclenol for the first MRI and then gadobutrol for the second MRI |
|
| gadobutrol-enhanced MRI then gadopiclenol-enhanced MRI | Experimental | Cross-over design: each patient receives gadobutrol for the first MRI and then gadopiclenol for the second MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gadopiclenol | Drug | Single intravenous bolus injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader. | At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States | ||
| UConn Health - University of Connecticut |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37462494 | Result | Kuhl C, Csoszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology. 2023 Jul;308(1):e222612. doi: 10.1148/radiol.222612. |
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Among the 324 screened patients,19 were screen failure, 1 received the first contrast agent but was not randomized. A total of 304 patients were randomized, of whom 300 (151 in Arm 1 and 149 in Arm 2) received the first contrast agent and underwent the first MRI (First MRI Period). After a washout period of 2-14 days, 277 patients (141 in the Arm 1 and 136 in the Arm 2) received the second contrast agent and underwent the second MRI (Second MRI Period). 275 patients completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI | Cross-over study design For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period). For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period. Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First MRI Examination |
|
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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 | Jun 30, 2020 | Oct 24, 2022 |
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| Gadobutrol 1 MMOLE/ML Intravenous Solution | Drug | Single intravenous bolus injection |
|
| At each of two MRI examinations with an interval of 2-14 days between two MRI examinations |
| Farmington |
| Connecticut |
| 06030-2802 |
| United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| UT Health San Antonio | San Antonio | Texas | 78207 | United States |
| Acibadem City Clinic Tokuda Hospital Sofia | Sofia | Bulgaria |
| CHU | Angers | France |
| CHU Beaujon | Clichy | France |
| Hôpital Saint Louis | Paris | France |
| Klinik für Diagnostische und Interventionelle Radiologie | Aachen | Germany |
| Universitätsklinikum Halle | Halle | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Germany |
| University Hospital Jena | Jena | Germany |
| Somogy Megyei Kaposi Mor Oktato Korhaz | Kaposvár | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | Hungary |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Naples | Italy |
| Clinical Research Institute S.C. | Estado de México | Mexico |
| Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center | Monterrey | Mexico |
| Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy | Bydgoszcz | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Jagiellońskie Centrum Innowacji Sp. z o. o. | Krakow | Poland |
| Szpital Świętego Rafała | Krakow | Poland |
| Centrum Medyczne Affidea Wałbrzych | Wałbrzych | Poland |
| Inje University Busan Paik Hospital | Busan | South Korea |
| Bucheon Suncheonhyang Hospital | Gyeonggi-do | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Hospital Universitario y Politécnico La Fe | Valencia | Spain |
| St. Luke's Hospital | Kropyvnytskyi | Ukraine |
| Borys Clinic | Kyiv | Ukraine |
| FG001 | Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI | Cross-over study design For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period). For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period. Gadobutrol 1Mmol/mL Solution for Injection Vial: single intravenous (IV) bolus injection at a rate of 2ml/second Gadopiclenol: single intravenous (IV) bolus injection at a rate of 2ml/second |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout |
|
|
| Second MRI Examination |
|
|
The analysis was based on participants. For the primary analysis to demonstrate the superiority of gadopiclenol-enhanced MRI compared to unenhanced MRI, the analysis population was patients who had both Pre (unenhanced) and Paired (combined unenhanced and contrast-enhanced) images with gadopiclenol assessable for primary criteria for at least one matching lesion for at least one off-site reader: 145 patients of Arm 1 who performed first MRI and 133 patients of Arm 2 who performed second MRI.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI | Cross-over study design For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period). For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period. |
| BG001 | Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI | Cross-over study design For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period). For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | Kg |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired [unenhanced and contrast-enhanced] images and Pre-contrast [unenhanced] images was calculated for each of the 3 co-primary criteria and for each reader. | Full Analysis Set (FAS) included a total of 278 patients who had both Pre and Paired images with gadopiclenol assessable for primary criteria for at least one matching lesion for at least one off-site reader: 145 patients in the Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients in the Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI. The analysis was based on participants (per patient). | Posted | Least Squares Mean | Standard Error | mean of a score (on a scale) per patient | At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI. |
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| Secondary | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor [internal morphology] or none [border delineation, contrast enhancement], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader. | Per-Protocol Set (PPS) analysis including 260 patients (135 patients in the Arm 1 and 125 patients in the Arm 2) with no major protocol deviation who have Paired (combined unenhanced and contrast-enhanced) images for both gadopiclenol and gadobutrol assessable for this secondary outcome mesure for at least one matching lesion for at least one off-site reader. The analysis was based on participants (per patient). | Posted | Least Squares Mean | Standard Error | mean of a score (on a scale) per patient | At each of two MRI examinations with an interval of 2-14 days between two MRI examinations |
|
Adverse events were recorded from informed consent signature up to one day after the second MRI (i.e., minimum of 4 days and a maximum of 23 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gadopiclenol | AEs reported after MRI with gadopiclenol | 0 | 288 | 3 | 288 | 50 | 288 |
| EG001 | Gadobutrol | AEs reported after MRI with gadobutrol | 0 | 290 | 0 | 290 | 58 | 290 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition Aggravated | General disorders | MedDRA 23.1 | Systematic Assessment | Not related to contrast-agent or study procedure |
|
| Depressed Level Of Consciousness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment | Not related to contrast-agent or study procedure |
|
| Covid-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment | Not related to contrast-agent or study procedure |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Monocytopenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Cystatin c increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Paracentesis | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Incorrect dosage administered | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 23.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
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| Swelling of eyelid | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Central venous catheterisation | Surgical and medical procedures | MedDRA 23.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frantz Hebert, Global Head of Clinical Development | Guerbet | +33 (0)6 80 24 93 34 | frantz.hebert@guerbet.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2021 | Oct 24, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656634 | gadopiclenol |
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| Adverse Event |
|
| Other reason |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hungary |
|
| United States |
|
| Ukraine |
|
| Poland |
|
| Italy |
|
| Mexico |
|
| France |
|
| Bulgaria |
|
| Germany |
|
| Spain |
|
| Border delineation - Reader 3 |
|
| Internal morphology - Reader 1 |
|
| Internal morphology - Reader 2 |
|
| Internal morphology - Reader 3 |
|
| Contrast enhancement - Reader 1 |
|
| Contrast enhancement - Reader 2 |
|
| Contrast enhancement - Reader 3 |
|
| Superiority |
| Criterion: Border delineation; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 0.47 | Standard Error of the Mean | 0.06 | 2-Sided | 95 | 0.36 | 0.58 | Superiority |
| Criterion: Border delineation; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 1.71 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | 1.65 | 1.78 | Superiority |
| Criterion: Internal morphology; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 1.81 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | 1.76 | 1.87 | Superiority |
| Criterion: Internal morphology; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 0.53 | Standard Error of the Mean | 0.06 | 2-Sided | 95 | 0.42 | 0.64 | Superiority |
| Criterion: Internal morphology; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 2.03 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | 1.95 | 2.11 | Superiority |
| Criterion: Contrast enhancement; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 2.64 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | 2.56 | 2.72 | Superiority |
| Criterion: Contrast enhancement; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 1.82 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | 1.68 | 1.96 | Superiority |
| Criterion: Contrast enhancement; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers. | t-test, 2 sided | <0.0001 | To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers. | Mean Difference (Final Values) | 2.33 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | 2.26 | 2.41 | Superiority |
Analysis included 260 patients with no major protocol deviation who have Paired (combined unenhanced and contrast-enhanced) images for both gadopiclenol and gadobutrol assessable for this secondary outcome mesure for at least one matching lesion for at least one off-site reader: 135 patients of Arm 1 and 125 patients of Arm 2.
The analysis was based on participants (per patient).
The 260 patients with gadopiclenol Paired images are the same patients with gadobutrol Paired images.
| OG001 | Patients With Gadobutrol Paired Images | Analysis included 260 patients with no major protocol deviation who have Paired (combined unenhanced and contrast-enhanced) images for both gadopiclenol and gadobutrol assessable for this secondary outcome mesure for at least one matching lesion for at least one off-site reader: 135 patients of Arm 1 and 125 patients of Arm 2. The analysis was based on participants (per patient). The 260 patients with gadobutrol Paired images are the same patients with gadopiclenol Paired images. |
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