Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

NCT07415018 | Not Yet Recruiting

• 2 other identifiers: 2025-1395NCI-2026-00997
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leptomeningeal Disease

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

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

OTHER

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).

Procedure: MRI Scan; Drug: VUEWAY; Drug: Gadavist

Interventions

MRI Scan PROCEDURE

Given during standard of care

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

VUEWAY DRUG

Given by IV

Also known as: gadopiclenol

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

Gadavist DRUG

Given by IV

Also known as: gadobutrol

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Meningeal Neoplasms

Interventions

Magnetic Resonance Spectroscopy; gadopiclenol; gadobutrol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Rami Eldaya, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Eldaya, MD

CONTACT

(713) 745-2945; reldaya@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): July 22, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)