An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
Recruiting now · Phase 2
Conditions studied: WHO Grade 3 Glioma, WHO Grade 4 Glioma
In brief
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.
Key facts
- Study ID
- NCT06444412
- Run by
- Mayo Clinic
- People needed
- 25
- Starts
- 2026-01-12
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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