An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2028-07-31

Brief Summary

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This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To assess the feasibility and immediate safety profile of gallium Ga 68 gozetotide (Ga-68 labeled PSMA-11) brain PET in patients with gliomas, assessed as the percentage of patients who experience grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11 occurring prior to the patient leaving the Nuclear Medicine department.

EXPLORATORY OBJECTIVES:

I. An exploratory investigation will be performed in regions of high tumor cell density (tumor recurrence) and low tumor cell density/treatment effect to determine whether PSMA-11 uptake differs significantly between true tumor progression vs. in radiation treatment effects by performing a radiology-pathology comparison of visual and descriptive features of the PET with biopsy.

II. To identify optimal maximum standardized uptake value (SUVmax) thresholds for differentiating viable tumor from treatment effect.

III. To perform a radiology-pathology correlation of PSMA uptake at PET with tumor PSMA immunohistochemistry (IHC) immunostaining, tumor pathology features, and signal and enhancement characteristics at magnetic resonance imaging (MRI) (no research MRI will be obtained, based on MRI images obtained for clinical use).

IV. To evaluate the added diagnostic value of Ga-68 PSMA-11 PET beyond MRI (using information from a clinical MRI\[s\] obtained prior to enrollment in the study) for detecting viable enhancing tumor from treatment effects.

OUTLINE:

Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT over 1 hour, 50-100 minutes after injection.

Conditions

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WHO Grade 3 Glioma WHO Grade 4 Glioma

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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Diagnostic (Ga-68 PSMA-11, PET/CT)

Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Ga 68 PSMA-11

Intervention Type DRUG

Contrast dye given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Ga 68 PSMA-11

Contrast dye given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga)Glu-urea-Lys(Ahx)-HBED-CC 68Ga-DKFZ-PSMA-11 68Ga-HBED-CC-PSMA 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC 68Ga-PSMA 68Ga-PSMA-11 68Ga-PSMA-HBED-CC [68Ga] Prostate-specific Membrane Antigen 11 [68Ga]GaPSMA-11 AAA 517 AAA-517 AAA517 Ga PSMA Ga-68 labeled DKFZ-PSMA-11 Ga-68 labeled PSMA-11 Ga 68 PSMA-11, Intravenous Solution Gallium Ga 68 PSMA-11 Gallium Ga 68-labeled PSMA-11 Gallium-68 PSMA Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC GaPSMA PSMA-HBED-CC GA-68 Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* History of World Health Organization (WHO) grade III or IV infiltrating glioma previously treated with first-line chemoradiotherapy.
* MRI findings compatible with contrast-enhancing recurrent infiltrating glioma.
* Planned craniotomy for resection of suspected disease recurrence.
* Willing to sign release of information for any radiation and/or follow-up records.
* Ability to provide informed written consent.
* Ability to provide tissue for mandatory correlative research component.

Exclusion Criteria

* Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
* Any of the following:

* Pregnant women
* Nursing women
* Men or women of childbearing potential unwilling to employ adequate contraception

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No