An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression… (NCT06444412) | Clinical Trial Compass
RecruitingPhase 2
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
United States25 participantsStarted 2026-01-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (safety and tolerability)
Timeframe: Up to 24 hours after 68Ga-PSMA-11 injection
2
Tolerability of PSMA positron emission tomography scan