New Gadolinium-Free MRI dye shows promise for brain scans
NCT ID NCT06322342
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new MRI contrast agent called RVP-001, made with manganese instead of gadolinium, in 18 adults with known brain lesions (like tumors or multiple sclerosis). The goal was to see if it is safe and can detect lesions as well as current gadolinium-based dyes. Each participant received one dose of RVP-001 and had their scans compared to earlier gadolinium-enhanced MRIs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RVP-001 (manganese-based MRI contrast agent)
- What this could lead to
- If successful, this could provide a safer, gadolinium-free alternative for MRI scans to detect brain lesions and tumors.
- What could go wrong
- This is a small, early-phase trial with only 18 participants, so results may not apply to everyone. The new agent may not work as well as current gadolinium-based contrasts.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
-
Dec 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 75 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults of all sexes, aged 18-75 years 2. Patients with known enhancing CNS lesions, including but not limited to gliomas, meningiomas, glioblastomas, schwannomas, brain metastases, multiple sclerosis lesions, that are on an ongoing follow-up MRI schedule 3. Patients who have had a GBCA-enhanced MRI within the past 14 days which demonstrated focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors, focal inflammatory disorders) including at least one enhancing lesion of minimum 5 mm (long axis) 4. Acceptable renal function Exclusion Criteria: 1. Serious non-malignant disease that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor 2. Body mass index (BMI) greater than 35 3. Patients with clinically significant cardiac disease 4. MRI incompatibility
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
-
Duke University Medical Center
Durham, North Carolina, 27710, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
-
University of Missouri
Columbia, Missouri, 65212, United States
-
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
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