Recruiting
Phase 2

Ga-68 PSMA-11

Sponsor:

Mayo Clinic

Code:

NCT06444412

Conditions

WHO Grade 3 Glioma

WHO Grade 4 Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Electronic Health Record Review

Ga 68 PSMA-11

Positron Emission Tomography

Study Details

Brief summary:

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 ID

NCT06444412

Start date

Jan 12, 2026

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Computed Tomography

Undergo PET/CT

Electronic Health Record Review

Ancillary studies

Ga 68 PSMA-11

Contrast dye given IV

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Adverse Events (safety and tolerability) [ Time Frame: Up to 24 hours after 68Ga-PSMA-11 injection ]
  • Tolerability of PSMA positron emission tomography scan [ Time Frame: Up to 60 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Brian J. Burkett, MD, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-22.