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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

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ClinicalTrials.gov Identifier: NCT04307186
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Central Nervous System Pathology Drug: BAY1747846 Drug: Gadobutrol (Gadovist/Gadavist) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This is a one-way crossover study with blinded participants and blinded image readers
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : October 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol

Arm Intervention/treatment
Experimental: BAY1747846 + Gadobutrol
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 BAY1747846.
Drug: BAY1747846
Solution for IV injection, single dose

Drug: Gadobutrol (Gadovist/Gadavist)
Solution for IV injection, single dose




Primary Outcome Measures :
  1. Overall diagnostic preference [ Time Frame: At 5 minute post injection ]
    Overall diagnostic preference will be evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer BAY1747846, prefer BAY1747846, no preference, prefer gadobutrol, greatly prefer gadobutrol)


Secondary Outcome Measures :
  1. Sum of lesion visualization parameters [ Time Frame: At 5 minute post injection ]
    Parameters include: border delineation (measured on a 4-point scale, ranging from 1=none to 4=excellent), contrast enhancement (measured on an 4-point scale, ranging from 1=none to 4=excellent), internal morphology (measured on an 3-point scale, ranging from 1=poor to 3=good).

  2. Lesion visualization parameter border delineation on pre-contrast and combined pre- and post-contrast images [ Time Frame: At pre-injection and 5 minute post injection ]
    Border delineation will be measured on a 4-point scale, ranging from 1=none to 4=excellent.

  3. Lesion visualization parameter contrast enhancement on pre-contrast and combined pre- and post-contrast images [ Time Frame: At pre-injection and 5 minute post injection ]
    Contrast enhancement will be measured on an 4-point scale, ranging from 1=none to 4=excellent.

  4. Lesion visualization parameter internal morphology on pre-contrast and combined pre- and post-contrast images [ Time Frame: At pre-injection and 5 minute post injection ]
    Internal morphology will be measured on an 3-point scale, ranging from 1=poor to 3=good.

  5. Number of lesions on pre-contrast and combined pre- and post-contrast images [ Time Frame: At pre-injection and 5 minute post injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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:

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307186


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04307186    
Other Study ID Numbers: 20241
2019-001560-30 ( EudraCT Number )
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
CNS