RecruitingPhase 2NCT06444412

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

GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Jan 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria5

  • 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

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Interventions

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERElectronic Health Record Review

Ancillary studies

DRUGGa 68 PSMA-11

Contrast dye given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06444412


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