Low-Dose Gadobutrol + AI for Brain Tumor Imaging

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Subtle Medical

Disqualifiers: Multiple sclerosis, Severe cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with known or highly suspected brain tumors. Participants must be suitable for MRI scans and contrast agents. Specific eligibility criteria are not provided, but typically include age, health status, and tumor characteristics.

Inclusion Criteria

I understand the study details and agree to participate.

Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.

Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS.

Exclusion Criteria

Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.

I have severe heart disease.

I have a diagnosis like multiple sclerosis that changes over time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment Period 1

Participants receive a standard dose gadobutrol (0.1 mmol/kg) for contrast-enhanced MRI

1 day

1 visit (in-person)

Washout

A washout period of at least 72 hours but less than 15 days between treatment periods

3-15 days

Treatment Period 2

Participants receive a low dose gadobutrol (0.01 mmol/kg or 0.025 mmol/kg) for contrast-enhanced MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Gadobutrol
• SubtleGAD

Trial Overview The study is testing if low doses of a contrast agent called Gadobutrol enhanced by AI software (SubtleGAD) can produce MR images as clear as those taken with standard higher doses. It's a randomized test comparing two different low-dose groups against the standard dose.

Participant Groups

Group I: Group A (10% dose GV) Active Control 2 Interventions

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.

Group II: Group B (25% dose GV) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Subtle Medical

Lead Sponsor

Trials

1

Recruited

60+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD