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NCT06224543 · ClinicalTrials.gov registry record · Phase 1
MR Image Synthesis With Low Gadobutrol Dose and AI
A Phase 1 study of Enhancing Brain Lesions, sponsored by Subtle Medical.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 5
- Study locations
NCT06224543 is a Phase 1 study of Enhancing Brain Lesions that has completed, run by Subtle Medical. The registered enrollment target is 60 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT06224543, a Phase 1 study of Enhancing Brain Lesions, has completed, sponsored by Subtle Medical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 5
- Study locations
Study 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 Studied
Interventions
- DRUG Gadobutrol
- DEVICE SubtleGAD
Study Locations (5)
Illinois
- Central Illinois Radiological Associates; OSF St. Francis Hospital Peoria - Peoria
Massachusetts
- UMass Chan Medical School - Worcester
Minnesota
- Mayo Clinic - Rochester
Pennsylvania
- The Pennsylvania State University - State College
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2025-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06224543
The ClinicalTrials.gov registry entry for NCT06224543 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Subtle Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Enhancing Brain Lesions appearing as the primary indexed condition, and to 2 interventions - of which Gadobutrol is the first listed.
NCT06224543 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Illinois, Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06224543 about?
NCT06224543 is a clinical study titled "MR Image Synthesis With Low Gadobutrol Dose and AI". 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 admi...
What is the current status of trial NCT06224543?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-06-16. Estimated completion is 2025-08-15.
What conditions does trial NCT06224543 study?
This clinical trial studies the following conditions: Enhancing Brain Lesions.
What interventions are being tested in trial NCT06224543?
The interventions under investigation include: Gadobutrol (DRUG), SubtleGAD (DEVICE).
Who is sponsoring clinical trial NCT06224543?
This trial is sponsored by Subtle Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06224543 being conducted?
This trial has 5 study locations across Illinois, Massachusetts, Minnesota, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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