About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia).
Pregnant women
Nursing women
Men or women of childbearing potential unwilling to employ adequate contraception
Trial design
Single group
Treatments tested in this trial
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Electronic Health Record Review
Other interventionAncillary studies
Ga 68 PSMA-11
DrugContrast dye given IV
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Treatment groups
Trial outcomes
Primary outcomes
Adverse Events (safety and tolerability)
Assessed as the percentage of patients who experience Grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11. Adverse effects will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Tolerability of PSMA positron emission tomography scan
Will assess any issues in completion of the PSMA positron emission tomography scans in these patients and summarize those in a descriptive manner.
Sponsors and contacts
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