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

Early Phase 1

Recruiting

• Conditions: High-grade Glioma; Brain Metastases, Adult; Brain Metastases
• Interventions: Diagnostic Test: 68Ga-PSMA-11 PET Scans

• Registration Number: NCT06209567
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-05
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-01-05
• Study Completion: 2027-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with high-grade glioma	68Ga-PSMA-11 PET Scans	Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

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

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States