A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

High-Grade Glioma Brain Diseases Brain Metastases Brain Metastases, Adult Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-PSMA-11 PET Scans

Diagnostic Test

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.

Primary outcomes

Assess range of tumor uptake of 68Ga-PSMA-11 in participants

Time frame: up to 12 months

Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jan 17, 2024
Registry last updated: Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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