Contrast-Enhanced MRI for Leptomeningeal Disease

Overseen By Rami Eldaya, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Positive CSF LMD, Implantable devices, Pregnancy, Pediatrics

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.

Who Is on the Research Team?

Rami Eldaya, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants able to consent.

I have a solid tumor and unclear or negative test results for leptomeningeal disease.

I am over 18 years old.

Exclusion Criteria

Participants with implantable devices that cannot be scanned with MR safe mode for participant safety.

Pregnant participants or potentially pregnant participants at risk of contrast on the fetus.

I have been diagnosed with leptomeningeal disease (LMD).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo brain MRI scans with gadopiclenol contrast to detect early LMD

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Gadavist
• VUEWAY

How Is the Trial Designed?

Group I: MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol) Experimental Treatment 3 Interventions

Participants found to be eligible to take part in this study and agree to take part, will have brain MRI scans as part of standard of care. Then, within a week (preferably within 48 hours) of the participants routine brain MRI scans, you will have LMD-focused brain MRI scans with gadopiclenol contrast. Specifically, MRI scans will be done immediately after a small amount of gadopiclenol is given through an IV catheter placed into a vein, and then at 10 and 30 minutes thereafter. Then, a second dose of gadopiclenol will be given, and MRI scans will be done immediately after. The MRI scans performed for research purposes will take approximately 50 minutes to complete. You will be followed by routing clinical and imaging guidelines for 6 months or until the confirmation of LMD (whichever comes first).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+