A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET
1 other identifier
interventional
11
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jan 2024
Typical duration for early_phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2024
CompletedFirst Submitted
Initial submission to the registry
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 5, 2027
December 3, 2025
December 1, 2025
3 years
January 8, 2024
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess range of tumor uptake of 68Ga-PSMA-11 in participants
Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax
up to 12 months
Study Arms (1)
Participants with high-grade glioma
EXPERIMENTALParticipants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Nosov, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 17, 2024
Study Start
January 5, 2024
Primary Completion (Estimated)
January 5, 2027
Study Completion (Estimated)
January 5, 2027
Last Updated
December 3, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.