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

Description

PRIMARY OBJECTIVE:

I. To assess uptake of Ga-68 labeled PSMA-11 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 versus (vs.) in radiation treatment effects.

SECONDARY OBJECTIVE:

I. To evaluate the immediate safety and tolerability of PSMA PET in patients with glioma.

EXPLORATORY OBJECTIVES:

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

II. 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).

III. To evaluate the added diagnostic value of gallium Ga 68 (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.