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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling
Early Phase 1

Conditions

Brain Metastases, Adult
Brain Metastases
High-grade Glioma

Treatments

Diagnostic Test: 68Ga-PSMA-11 PET Scans

Study type

Interventional

Funder types

Other

Identifiers

NCT06209567
23-382

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Participants with high-grade glioma
Experimental group
Description:
Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases
Treatment:
Diagnostic Test: 68Ga-PSMA-11 PET Scans

Trial contacts and locations

7

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Central trial contact

Elizabeth Coffee, MD; Simone Krebs, MD

Data sourced from clinicaltrials.gov

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