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

NCT ID: NCT04307186

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-18
• Study Completion Date: 2022-09-06

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gadobutrol + Gadoquatrane

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).

Group Type: EXPERIMENTAL

Gadoquatrane (BAY1747846)

Intervention Type: DRUG

Solution for IV injection, single dose

Gadobutrol (Gadovist/Gadavist)

Intervention Type: DRUG

Solution for IV injection, single dose

Interventions

Gadoquatrane (BAY1747846)

Solution for IV injection, single dose

Intervention Type: DRUG

Gadobutrol (Gadovist/Gadavist)

Solution for IV injection, single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern University

Chicago, Illinois, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

UMHAT Sveti Georgi

Plovdiv, , Bulgaria

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, , Bulgaria

University Multiprofile Hosp. for Active Treat. Sveti Ivan

Sofia, , Bulgaria

MVZ Prof. Uhlenbrock und Partner

Dortmund, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Friedrich-Schiller-Uni. Jena

Jena, Thuringia, Germany

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, Japan

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

National Hospital Organization Kanmon Medical Center

Shimonoseki, Yamaguchi, Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, , Japan

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, , Japan

Countries

United States; Bulgaria; Germany; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

2019-001560-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20241

Identifier Type: -

Identifier Source: org_study_id