Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

April 13, 2026 updated by: M.D. Anderson Cancer Center
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 ranging from 33% in hematological malignancies in some studies to 75% (7, 8). This limits detection of early LMD thus potentially delaying diagnosis and initiation of life-saving treatment. We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to optimize an LMD specific MR brain protocol to improve MR ability to detect early LMD disease.
  • Secondary Objectives Secondary Aim: Establish the ideal protocol and dose of VUEWAY® (gadopiclenol) for the detection of parenchymal brain metastatic disease. Brain MRI is the primary modality for detection and screening of intracranial metastasis. Brain MRI detects metastasis in 70% of participants that are asymptomatic at the time of diagnosis (9). However, sensitivity of MR for detection of smaller metastasis depends on acquisition sequences, dose of contrast, and timing of scanning after contrast administration (10-12). We hypothesize that the excellent relaxivity of VUEWAY® (gadopiclenol) coupled with its safety profile including lower dosage compared to other contrast agents can be utilized to increase detection of smaller parenchymal metastatic lesions on brain MR exams. Furthermore, in addition to serving as aim 2 for this study, this will serve as an internal control for quality assessment for aim 1.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Rami Eldaya, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Procedure: MRI Scan
Given during standard of care
Drug: VUEWAY
Given by IV
Other Names:
  • gadopiclenol
Drug: Gadavist
Given by IV
Other Names:
  • gadobutrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Rami Eldaya, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 22, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1395
  • NCI-2026-00997 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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