Central Nervous System PathologyPhase 2NCT04307186
Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
A Phase 2 study testing Gadoquatrane (BAY1747846) and Gadobutrol (Gadovist/Gadavist) in people with Central Nervous System Pathology, run by Bayer at 17 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Pathology
- What is being tested?
- Gadoquatrane (BAY1747846) and Gadobutrol (Gadovist/Gadavist)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 18 Nov 2020to 6 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be at least 18 years of age at the time of signing the informed consent.
- Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS.
- Male and female.
- Estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.
Who cannot join
- 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.
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- Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI:
- Lepto-meningeal disease (e.g. leptomeningeal carcinomatosis). Dural lesions (e.g. meningiomas) fulfilling inclusion criteria #2 are not excluded
- Pituitary adenomas (macro and micro)
- Tumors of the choroid plexus
- Tumors of the pineal gland
- Dermoid/epidermoid tumors
- Infectious disease (e.g. brain abscess, cisticercosis, etc.)
- Venous angiomas
- Subacute/chronic ischemia
- Encephalitis
- Multiple sclerosis (acute and chronic)
- Optic neuritis
- Chordomas
- Von Hippel Lindau syndrome
- Hypertensive leukoencephalopathy.
- 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.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Japan8 sites
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, 811-0213
National Hospital Organization Himeji Medical Center
Himeji, Hyōgo, 670-8520
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, 662-0918
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
National Hospital Organization Kanmon Medical Center
Shimonoseki, Yamaguchi, 752-8510
United States3 sites
Northwestern University
Chicago, Illinois, 60611
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242-1089
Bulgaria3 sites
UMHAT Sveti Georgi
Plovdiv, 4002
Acibadem City Clinic Multiprofile Hospital for Active Treatm
Sofia, 1407
University Multiprofile Hosp. for Active Treat. Sveti Ivan
Sofia, 1431
Germany3 sites
MVZ Prof. Uhlenbrock und Partner
Dortmund, North Rhine-Westphalia, 44263
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Friedrich-Schiller-Uni. Jena
Jena, Thuringia, 07740
About this study
Official title: Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS
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.
- Conditions
- Central Nervous System Pathology
- Being tested
- Gadoquatrane (BAY1747846), Gadobutrol (Gadovist/Gadavist)
- Keywords
- CNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoquatrane (BAY1747846)Drug
Solution for IV injection, single dose
Gadobutrol (Gadovist/Gadavist)Drug
Solution for IV injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol (Gadovist/Gadavist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 5 minute post each injection
Secondary outcomes (5)
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]).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At pre-injection and 5 minute post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start18 Nov 2020
- Primary completion5 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Nervous System PathologyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307186
- Sponsor's protocol ID
- 20241
- Other IDs
- 2019-001560-30, 2019
- Status last verified
- Oct 2023
- First submitted
- 11 Mar 2020
- Last updated
- 15 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS
- ClinicalTrials.gov ID
- NCT04307186
- Acronym / sponsor ID
- 20241
- Conditions
- Central Nervous System Pathology
- Keywords
- CNS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 15 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol + Gadoquatrane | Experimental | Drug: Gadoquatrane (BAY1747846), Drug: Gadobutrol (Gadovist/Gadavist)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be at least 18 years of age at the time of signing the informed consent.
- Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for contrast-enhanced MRI of the CNS.
- Male and female.
- Estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadoquatrane (BAY1747846)Solution for IV injection, single dose | Drug | Gadobutrol + Gadoquatrane |
| Gadobutrol (Gadovist/Gadavist)Solution for IV injection, single dose | Drug | Gadobutrol + Gadoquatrane |
Primary outcome
Overall Diagnostic Preference
Time frame: At 5 minute post each injection
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.
5 secondary outcomes
Sum of Lesion Visualization Parameters on Post-contrast Images
Time frame: At 5 minute post each injection
Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
Time frame: At pre-injection and 5 minute post each injection
Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
Time frame: At pre-injection and 5 minute post each injection
Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
Time frame: At pre-injection and 5 minute post each injection
Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
Time frame: At pre-injection and 5 minute post injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gadoquatrane (BAY1747846) and Gadobutrol (Gadovist/Gadavist) in people with Central Nervous System Pathology, run by Bayer at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan, United States, Bulgaria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Diagnostic Preference (time frame: At 5 minute post each injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.