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

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.

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 biopsy or 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