Leptomeningeal Disease
Conditions
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 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.
Interventions
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | 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 |
Countries
United States
Contacts
CONTACTRami Eldaya, MD
PRINCIPAL_INVESTIGATORRami Eldaya, MD
M.D. Anderson Cancer Center
Outcome results
None listed