MR Image Synthesis With Low Gadobutrol Dose and AI

NCT06224543 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 22403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

Study 22403 is a Phase 1 / Proof of Concept exploratory investigation to assess the non-inferiority of low dose gadobutrol and SubtleGAD™, a software medical device using an Artificial Intelligence (AI) deep learning-based method to enhance the contrast signal from images acquired with low dose administration of gadobutrol (GAD) contrast. The primary objective is to demonstrate noninferiority of synthesized Central Nervous System (CNS) magnetic resonance (MR) images for 1 or 2 different gadobutrol-enhanced low-dose groups (0.01mmol/kg, and0.025 mmol/kg) compared to gadobutrol-enhanced CNS MR images at a standard dose of 0.1 mmol/kg. This investigation is a prospective, randomized, open label, multi-center study with blinded reads in participants with known or highly suspected CNS pathology. There will be at least 60 participants enrolled (30 per study arm). SubtleGAD will be used as a post-processing tool, prior to blinded read assessment of MR images acquired in either arm of the study.

Conditions

Enhancing Brain Lesions

Outcome Measures

Primary Outcomes (1)

• Compare enhancement of SubtleGAD in 10% dose and 25% dose gadobutrol MR images.

  Compare enhancing lesions in gadobutrol-enhanced central nervous system (CNS) magnetic resonance imaging (MRI) low dose groups (0.01 mmol/kg, 0.025 mmol/kg), and standard dose (0.1 mmol/kg).

  4 to 15 days

Study Arms (2)

Group A (10% dose GV)

ACTIVE COMPARATOR

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and 10% dose gadobutrol (0.01 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (10% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Device: SubtleGAD; Drug: Gadobutrol

Group B (25% dose GV)

ACTIVE COMPARATOR

Each participant will receive a Standard dose gadobutrol (0.1 mmol/kg) in Period 1 and Study Period 2: 25% dose gadobutrol (0.025 mmol/kg) in Period 2. During study Period 1, each participant will receive gadobutrol as a single intravenous (IV) administration at the standard dose for contrast-enhanced MRI followed by study Period 2 where a single IV low dose (25% dose) of gadobutrol will be administered. There will be a washout period of at least 72 hours but less than 15 days between the two periods. The individual study duration will therefore range from 4 to 15 days.

Device: SubtleGAD; Drug: Gadobutrol

Interventions

SubtleGAD DEVICE

SubtleGAD is an image processing software developed to enhance MR images acquired with low dose gadobutrol.

Group A (10% dose GV); Group B (25% dose GV)

Gadobutrol DRUG

Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients including term neonates to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

Also known as: Gadavist Injection

Group A (10% dose GV); Group B (25% dose GV)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age.
• Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.
• Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m\^2.
• Be fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and being capable and willing to consent to participate.

You may not qualify if:

• Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.
• Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
• Brain pathology or abnormalities that are not considered lesions.
• Any contraindication for MRI procedure or gadobutrol administration.
• Has severe cardiovascular disease.
• Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability.
• Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI.
• Women currently lactating, pregnant, or planning on becoming pregnant during the study.
• Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration.
• Receipt of any gadolinium-based contrast agent \<72 hours prior to the study MRIs.
• Participants with acute kidney injury.

Sponsors & Collaborators

• Subtle Medical: lead
• Bayer: collaborator

Study Sites (5)

Central Illinois Radiological Associates; OSF St. Francis Hospital Peoria

Peoria, Illinois, 61637, United States

Location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Pennsylvania State University

State College, Pennsylvania, 16801, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

gadobutrol

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two interventional groups: Group A: 0.01 mmol/kg GV, Group B: 0.025 mmol/kg GV. Both groups also receive GV standard dose (0.1 mmol/kg) that serves as the clinical image set for the participant and as comparator.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: June 16, 2023
• Primary Completion: July 7, 2025
• Study Completion: August 15, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)