Clinical Trial · NCT06444412

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

Overview

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.

Sponsor

Mayo Clinic

Phase

Phase 2

Contacts

Brian J. Burkett, MD, MPH (PRINCIPAL_INVESTIGATOR)

Clinical Trials Referral Office (CONTACT)

mayocliniccancerstudies@mayo.edu

855-776-0015

ClinicalTrials.gov

NCT06444412

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC
Linker: Ahx

Eligibility

Inclusion

  • Ability to provide tissue for mandatory correlative research component.
  • 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.

Exclusion

  • Pregnant women
  • Nursing women
  • Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
  • Men or women of childbearing potential unwilling to employ adequate contraception
  • Any of the following: