Recruiting

Gadopiclenol

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07415018

Conditions

Leptomeningeal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI Scan

VUEWAY

Gadavist

Study Details

Brief summary:

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

Conditions

Leptomeningeal Disease

Study ID

NCT07415018

Start date

Jun 10, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with tissue confirmed solid malignancy and standard of care brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or patients with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more patients are needed to meet the study power we will enroll liquid tumors.
  • Participants > 18 years of age.
  • Participants are able to consent.

Exclusion Criteria:

  • Participants with CSF sampling positive for LMD or MR brain/spine with definitive evidence of LMD.
  • Participants with implantable devices that can not be scanned with MR safe mode for participant safety.
  • Pregnant participants or potentially pregnant participants are at risk of contrast on the fetus

Pediatric participants < 18 years of age.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)

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).

Interventions

MRI Scan

Given during standard of care

VUEWAY

Given by IV

Gadavist

Given by IV

Primary outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Rami Eldaya, MD

(713) 745-2945reldaya@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Rami Eldaya, MD

713-745-2945reldaya@mdanderson.org

Principal Investigator:

Rami Eldaya, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-18.