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

Description

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.

Conditions

WHO Grade 3 Glioma, WHO Grade 4 Glioma

Study Overview

Study Details

Study 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.

GA-68 PSMA-11 PET to Evaluate Malignant Glioma Recurrence - a Pilot Study

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

Condition
WHO Grade 3 Glioma
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Previous treatment with antiangiogenic therapy (e.g. bevacizumab).
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Brian J. Burkett, MD, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2026-04-30