An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
NCT06444412 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-01-14
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
Interventions
- PROCEDURE
-
Computed Tomography
Undergo PET/CT
- OTHER
-
Electronic Health Record Review
Ancillary studies
- DRUG
-
Ga 68 PSMA-11
Contrast dye given IV
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Brian J. Burkett, MD, MPH · Mayo Clinic in Rochester
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-12
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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