Brain Metastases, Brain Metastases, Adult, High-grade Glioma
Conditions
Keywords
68Ga-PSMA-11, High-grade Glioma, Brain Metastases, 23-382, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.
Interventions
DIAGNOSTIC_TEST68Ga-PSMA-11 PET Scans
Participants will be injected intravenously with 68Ga-PSMA-11 via intravenous catheter. PET scans will first be interpreted without information on the results of other imaging modalities. Following the blinded read of the 68Ga-PSMA-11 PET scans, all recorded findings will be correlated with the results of CE CT and MR studies and 18F-FDG PET/CT or PET/MR performed as part of standard clinical care.
Sponsors
Memorial Sloan Kettering 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
* Ability to understand and the willingness to sign (or their legally acceptable representative (LAR) must sign) a written informed consent document * Adults ≥ 18 years old * Suspicion for or histologically or cytologically confirmed and previously treated HGG or brain metastases from a primary extracranial malignancy * Lesion size ≥ 1 cm (for the lesion to be biopsied) * ECOG performance status ≤ 2 (Karnofsky ≥ 60%) * Planned to undergo biopsy/resection of brain lesion
Exclusion criteria
* Inability to undergo a PET scan (e.g., claustrophobia or noncompatible implant in case PET/MR is performed) * Pregnant or nursing female. All women of childbearing potential must have a documented negative serum or urine pregnancy test \<1 week before study. * Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with severe allergy to both iodinated and gadolinium contrast.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess range of tumor uptake of 68Ga-PSMA-11 in participants | up to 12 months | Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax |
Countries
United States
Outcome results
None listed