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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2027-01-05

Brief Summary

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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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Detailed Description

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Conditions

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High-grade Glioma Brain Metastases Brain Metastases, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participants with high-grade glioma

Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases

Group Type EXPERIMENTAL

68Ga-PSMA-11 PET Scans

Intervention Type 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.

Interventions

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68Ga-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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No