Clinical trial NCT04307186: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Nervous System Pathology
Keywords: CNS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

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.

Primary outcomes:
measure: Overall Diagnostic Preference
timeFrame: At 5 minute post each injection
Secondary outcomes:
measure: Sum of Lesion Visualization Parameters on Post-contrast Images
timeFrame: At 5 minute post each injection
measure: Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images
timeFrame: At pre-injection and 5 minute post each injection
measure: Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images
timeFrame: At pre-injection and 5 minute post each injection
measure: Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images
timeFrame: At pre-injection and 5 minute post each injection
measure: Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images
timeFrame: At pre-injection and 5 minute post injection
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm
city: Sofia
country: Bulgaria
facility: University Multiprofile Hosp. for Active Treat. Sveti Ivan
city: Dortmund
country: Germany
facility: MVZ Prof. Uhlenbrock und Partner
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Jena
country: Germany
facility: Friedrich-Schiller-Uni. Jena
state: Thüringen
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo Prefectural Nishinomiya Hospital
state: Hyogo
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Shimonoseki
country: Japan
facility: National Hospital Organization Kanmon Medical Center
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital
Study officials:
References: