Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease

ConditionLeptomeningeal Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

MRI Scan
Procedure/Surgery
Given during standard of care
VUEWAY
Drug
Given by IV
Gadavist
Drug
Given by IV

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: MRI Scan with Gadavist (gadobutrol) / VUEWAY (gadopiclenol)Other 3 interventions

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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