Clinical trial · Interventional
Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
NCT07415018CI-TRIAL-00115312recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Disease | Leptomeningeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadavist | Drug | — | UNRESOLVED |
| MRI Scan | Procedure | — | UNRESOLVED |
| VUEWAY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)
- description
- 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).
- interventionNames
- Procedure: MRI Scan
- Drug: VUEWAY
- Drug: Gadavist
Primary outcomes (1)
- measure
- Safety and adverse events (AEs)
- timeFrame
- Through study completion; an average of 1 year.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.