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

NCT04307186 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 202412019-001560-30
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 17

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

Keywords

CNS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Sum of Lesion Visualization Parameters on Post-contrast Images

  At 5 minute post each injection

• Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images

  At pre-injection and 5 minute post each injection

• Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images

  At pre-injection and 5 minute post each injection

• Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images

  At pre-injection and 5 minute post each injection

• Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images

  At pre-injection and 5 minute post injection

Study Arms (1)

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).

Drug: Gadoquatrane (BAY1747846); Drug: Gadobutrol (Gadovist/Gadavist)

Interventions

Gadoquatrane (BAY1747846) DRUG

Solution for IV injection, single dose

Gadobutrol + Gadoquatrane

Gadobutrol (Gadovist/Gadavist) DRUG

Solution for IV injection, single dose

Gadobutrol + Gadoquatrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (17)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242-1089, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatm

Sofia, 1407, Bulgaria

Location

University Multiprofile Hosp. for Active Treat. Sveti Ivan

Sofia, 1431, Bulgaria

Location

MVZ Prof. Uhlenbrock und Partner

Dortmund, North Rhine-Westphalia, 44263, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Friedrich-Schiller-Uni. Jena

Jena, Thuringia, 07740, Germany

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, 670-8520, Japan

Location

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, 662-0918, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, 596-0042, Japan

Location

National Hospital Organization Kanmon Medical Center

Shimonoseki, Yamaguchi, 752-8510, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, 811-0213, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Interventions

gadobutrol

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer AG

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is a one-way crossover study with blinded participants and blinded image readers
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: November 18, 2020
• Primary Completion: September 5, 2022
• Study Completion: September 6, 2022
• Last Updated: November 15, 2023
• Results First Posted: November 15, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (3); JP (8); DE (3); US (3)