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Investigating Ga-68 PSMA-11 PET/CT for Glioma Recurrence

This study is looking at a special type of scan called gallium-68 (Ga-68) PSMA-11 PET/CT. It's for people with Grade 3 or 4 glioma whose cancer might be coming back or getting worse after initial treatment. Doctors often use imaging to check on glioma, but it can be hard to tell if changes on scans are due to the cancer returning or just side effects from past treatments. This study wants to see if the Ga-68 PSMA-11 PET/CT scan can help tell the difference. The main goal is to check the safety of the scan and how well people tolerate it. About 25 people will participate in this study.

Study design
This is an interventional study, meaning participants will receive a specific intervention (the PET/CT scan). It aims to enroll 25 participants with Grade 3 or 4 glioma.
What's involved
You would undergo a PET/CT scan, which involves receiving Ga-68 PSMA-11 contrast dye intravenously (into a vein). Your electronic health records will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured up to 24 hours after the injection and up to 60 days for the scan's tolerability.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06444412

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Mayo Clinic
~25 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Computed TomographyElectronic Health Record ReviewGa 68 PSMA-11Positron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events (safety and tolerability)
Measured over Up to 24 hours after 68Ga-PSMA-11 injection
+1 more outcome measured

Conditions

WHO Grade 3 Glioma
WHO Grade 4 Glioma

Explore related trials

GliomaFOLH1 Gene

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Brian J. Burkett, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Adverse Events (safety and tolerability)Up to 24 hours after 68Ga-PSMA-11 injection

    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 scanUp to 60 days

    Will assess any issues in completion of the PSMA positron emission tomography scans in these patients and summarize those in a descriptive manner.