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Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease 40

Not yet recruiting
Clinical Trial NCT07415018 is an interventional study for Leptomeningeal Disease and is currently not yet recruiting. Enrollment is planned to begin on July 22, 2026 and continue until the study accrues 40 participants. Led by M.D. Anderson Cancer Center, this study is expected to complete by July 31, 2029. The latest data from ClinicalTrials.gov was last updated on February 17, 2026.
Brief Summary
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Detailed Description
  • Primary Objectives Primary Aim: Establish the ability of VUEWAY® (gadopiclenol) to detect early CNS LMD in brain MR while optimizing the ideal scan parameters including dose, sequences, and optimal timing for detection of CNS LMD in brain MRI. Brain MR offers a noninvasive alternative/complementary method to CNS sampling for detection of LMD. However, sensitivity for disease detection remains acceptable at best ran...
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Official Title

Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

Conditions
Leptomeningeal Disease
Other Study IDs
  • 2025-1395
  • NCI-2026-00997 (Other Identifier) (NCI-CTRP Clinical Registry)
NCT ID Number
NCT07415018
Start Date (Actual)
2026-07-22
Last Update Posted
2026-02-17
Completion Date (Estimated)
2029-07-31
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherMRI 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 cathete...Show More
MRI Scan
Given during standard of care
VUEWAY
Given by IV
Gadavist
Given by IV
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Participants with tissue confirmed solid malignancy and brain MRI with equivocal results for LMD (questionable or possible) and negative LP CSF sampling or participants with high risk clinical LMD and negative brain MR and LP CSF sampling. Initially, we will target solid tumors, but if more participants are needed to meet the study power we will enroll liquid tumors.
  • Participants > 18 years of age.
  • Participants are able to consent.

  • 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.

M.D. Anderson Cancer Center logoM.D. Anderson Cancer Center
Study Central Contact
Contact: Rami Eldaya, MD, (713) 745-2945, [email protected]
1 Study Locations in 1 Countries

Texas

MD Anderson Cancer Center, Houston, Texas, 77030, United States
Rami Eldaya, MD, Contact, 713-745-2945, [email protected]
Rami Eldaya, MD, Principal Investigator