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AI could slash contrast dye needed for brain scans

NCT ID NCT06224543

Diagnosis Sponsor: Subtle Medical Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether artificial intelligence (AI) software called SubtleGAD can enhance brain MRI images taken with a low dose of gadobutrol contrast dye, making them as clear as images taken with the standard higher dose. Sixty adults with known or suspected brain lesions received either a low dose (10% or 25% of standard) or the standard dose of contrast. The AI software was then used to improve the low-dose images. The goal is to see if this approach can reduce the amount of contrast dye patients need, potentially lowering risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gadobutrol (Gadavist) contrast agent
What this could lead to
If successful, this could allow patients to receive lower doses of contrast dye during brain MRIs, reducing potential risks while maintaining image quality.
What could go wrong
This is an early Phase 1 proof-of-concept study with only 60 participants. The AI-enhanced images may not match standard-dose quality in all cases, and results may not apply to all types of brain lesions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age. 2. Have known or highly suspected brain lesions referred for contrast-enhanced MRI of the CNS. 3. Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m\^2. 4. 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. Exclusion Criteria: 1. Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study. 2. Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up. 3. Brain pathology or abnormalities that are not considered lesions. 4. Any contraindication for MRI procedure or gadobutrol administration. 5. Has severe cardiovascular disease. 6. Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability. 7. 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. 8. Women currently lactating, pregnant, or planning on becoming pregnant during the study. 9. Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration. 10. Receipt of any gadolinium-based contrast agent \<72 hours prior to the study MRIs. 11. Participants with acute kidney injury.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Enhancing brain lesions

Contacts and locations

Locations

  • Central Illinois Radiological Associates; OSF St. Francis Hospital Peoria

    Peoria, Illinois, 61637, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • The Pennsylvania State University

    State College, Pennsylvania, 16801, United States

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655, United States