Optimizing Contrast Dose and Scanning Parameters for Detection of Leptomeningeal Disease
Purpose
To learn if gadopiclenol (a contrast agent) used during MRI scanning can help in the detection of early LMD.
Condition
- Leptomeningeal Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
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.