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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001560-30 | EudraCT Number |
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Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for Magnetic resonance imaging which produces body pictures created by using magnetic energy rather than x-ray energy.
Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new GBCA under development with the goal to provide similar imaging performances in MRI. Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 - 14 days in between. A MRI examination will be performed after each injection. Participant will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol + Gadoquatrane | Experimental | Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoquatrane (BAY1747846) | Drug | Solution for IV injection, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Diagnostic Preference | Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken. | At 5 minute post each injection |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Lesion Visualization Parameters on Post-contrast Images | The 3 lesion visualization parameters (border delineation/degree of contrast enhancement/internal morphology) were combined by adding them up for each participant and each blinded reader, leading to only one variable on an ordinal 11-point scale (the higher values represent a better lesion visualization). Average reader was the mean of the 3 blinded readers averages of the scores per participant. Lesion border delineation: measured on a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]). Degree of lesion contrast enhancement: measured on a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]). Lesion internal morphology: measured on a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]). |
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Inclusion Criteria:
Exclusion Criteria:
Considered clinically unstable or has a concomitant/intercurrent condition (e.g. COVID-19 infection) that would not allow participation for the full planned study period (i.e. period 1, 2 or both) in the judgement of the investigator.
Severe cardiovascular disease.
Patients undergoing liver transplantation.
Any contraindication to MRI examinations.
History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances.
History of allergic asthma and/ or atopic dermatitis.
Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI:
Receipt of any contrast agent < 72 h prior to the study MRIs, or planned receipt of any contrast agent within 72 h after the second study MRI.
Planned or expected biopsy in the region of interest or any interventional therapeutic procedure from the first study MRI up to 24 h after the second study MRI.
Planned or expected change in any treatment or procedure between the two study MRIs that may alter image comparability and /or chemotherapy which is changed between the two MRI procedures.
Contraindications to the administration of gadobutrol, as specified in the local product label.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| University of Iowa Hospitals & Clinics |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Of the 62 screened participants 5 were screening failures, resulting in 57 participants assigned to treatment who started with gadobutrol.
Study was conducted at 17 study centers in 4 countries between 18-Nov-2020 (first participant first visit) and 6-Sep-2022 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadobutrol + Gadoquatrane | Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 - Gadobutrol |
|
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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 | Jan 6, 2022 | Sep 4, 2023 |
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This is a one-way crossover study with blinded participants and blinded image readers
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| Gadobutrol (Gadovist/Gadavist) |
| Drug |
Solution for IV injection, single dose |
|
| At 5 minute post each injection |
| Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images | Lesion border delineation: up to 5 of the largest lesions were selected and scored using a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]; the higher values represent a better lesion border delineation). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | At pre-injection and 5 minute post each injection |
| Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images | Degree of lesion contrast enhancement: up to the 5 largest lesions were selected and scored using a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]; the higher values represent a better degree of lesion contrast enhancement). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | At pre-injection and 5 minute post each injection |
| Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images | Lesion internal morphology: up to 5 of the largest lesions were selected and scored using a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]; the higher values represent a better lesion internal morphology). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | At pre-injection and 5 minute post each injection |
| Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images | The 3 blinded readers recorded the total number of lesions for each pre-contrast and combined pre- and post-contrast magnetic resonance image set separately. The numbers of participants by number of detected lesions were reported. | At pre-injection and 5 minute post injection |
| Iowa City |
| Iowa |
| 52242-1089 |
| United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| UMHAT Sveti Georgi | Plovdiv | 4002 | Bulgaria |
| Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia | 1407 | Bulgaria |
| University Multiprofile Hosp. for Active Treat. Sveti Ivan | Sofia | 1431 | Bulgaria |
| MVZ Prof. Uhlenbrock und Partner | Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| Friedrich-Schiller-Uni. Jena | Jena | Thuringia | 07740 | Germany |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| National Hospital Organization Himeji Medical Center | Himeji | Hyōgo | 670-8520 | Japan |
| Hyogo Prefectural Nishinomiya Hospital | Nishinomiya | Hyōgo | 662-0918 | Japan |
| Kishiwada Tokushukai Hospital | Kishiwada | Osaka | 596-0042 | Japan |
| National Hospital Organization Kanmon Medical Center | Shimonoseki | Yamaguchi | 752-8510 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital | Fukuoka | 811-0213 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | 730-8518 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| Washout 3-14 Days |
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| Period 2 - Gadoquatrane |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadobutrol + Gadoquatrane | Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1 and one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2. |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Diagnostic Preference | Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken. | Full analysis set (FAS): All participants who have completed magnetic resonance (MR) image datasets that qualify for blinded read. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 5 minute post each injection |
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| Secondary | Sum of Lesion Visualization Parameters on Post-contrast Images | The 3 lesion visualization parameters (border delineation/degree of contrast enhancement/internal morphology) were combined by adding them up for each participant and each blinded reader, leading to only one variable on an ordinal 11-point scale (the higher values represent a better lesion visualization). Average reader was the mean of the 3 blinded readers averages of the scores per participant. Lesion border delineation: measured on a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]). Degree of lesion contrast enhancement: measured on a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]). Lesion internal morphology: measured on a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]). | Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read. | Posted | Mean | Standard Deviation | Scores on a scale | At 5 minute post each injection |
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| Secondary | Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images | Lesion border delineation: up to 5 of the largest lesions were selected and scored using a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]; the higher values represent a better lesion border delineation). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read. | Posted | Mean | Standard Deviation | Scores on a scale | At pre-injection and 5 minute post each injection |
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| Secondary | Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images | Degree of lesion contrast enhancement: up to the 5 largest lesions were selected and scored using a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]; the higher values represent a better degree of lesion contrast enhancement). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read. | Posted | Mean | Standard Deviation | Scores on a scale | At pre-injection and 5 minute post each injection |
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| Secondary | Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images | Lesion internal morphology: up to 5 of the largest lesions were selected and scored using a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]; the higher values represent a better lesion internal morphology). Average reader was the mean of the 3 blinded readers averages of the scores per participant. | Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read. | Posted | Mean | Standard Deviation | Scores on a scale | At pre-injection and 5 minute post each injection |
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| Secondary | Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images | The 3 blinded readers recorded the total number of lesions for each pre-contrast and combined pre- and post-contrast magnetic resonance image set separately. The numbers of participants by number of detected lesions were reported. | Full analysis set (FAS): All participants who have completed magnetic resonance image datasets that qualify for blinded read. | Posted | Number | Participants | At pre-injection and 5 minute post injection |
|
Adverse events tables: up to the 24 h ± 4 h follow-up time point following Gadobutrol or Gadoquatrane injection. All-cause mortality table: after signing informed consent up to the last contact per participant, up to 36 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 | Gadobutrol | Participants received one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) during treatment Period 1. | 0 | 57 | 0 | 57 | 3 | 57 |
| EG001 | Gadoquatrane | Participants received one IV injection of gadoquatrane (BAY1747846) 0.04 mmol Gd/kg bw during treatment Period 2. | 0 | 52 | 0 | 52 | 2 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (25.1) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (25.1) | Non-systematic Assessment |
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A written manuscript of any oral/written publication relating to the trial, the investigational medicinal products or the results shall be submitted to Bayer for review at least 60 days before the planned filing or presentation of the publication. If Bayer does not confirm receipt of the intended publication within 45 days, Bayer must be informed again of the intended publication date. If Bayer does not comment on the publication within the 60-day period, the publication is free to be published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2022 | Sep 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Reader 2 (1) |
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| Reader 2 (0) |
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| Reader 2 (-1) |
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| Reader 3 (1) |
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| Reader 3 (0) |
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| Reader 3 (-1) |
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Reader 2 |
| McNemar |
| 0.5775 |
P-Value was calculated. p < 0.05 indicates a difference between the two reads; p > 0.05 indicates the observed data do not contradict equality. |
| Other |
McNemar test was used for the exploratory analysis of difference between the percentage of participants "greatly prefer/prefer gadoquatrane" and "greatly prefer/prefer gadobutrol". |
| Reader 3 | McNemar | 0.3173 | P-Value was calculated. p < 0.05 indicates a difference between the two reads; p > 0.05 indicates the observed data do not contradict equality. | Other | McNemar test was used for the exploratory analysis of difference between the percentage of participants "greatly prefer/prefer gadoquatrane" and "greatly prefer/prefer gadobutrol". |
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| Gadoquatrane Combined Pre- and Post-contrast |
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane. |
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| OG003 |
| Gadoquatrane Combined Pre- and Post-contrast |
Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane. |
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| OG003 | Gadoquatrane Combined Pre- and Post-contrast | Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane. |
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Evaluation of the combined MR image sets taken before and 5 min after receiving IV injection of gadoquatrane.
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