Investigational imaging for detecting glioma recurrence or progression
Official title: GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study
Run by Mayo Clinic · NCT06444412 · Data updated 2026-11-12
This study is testing a new type of imaging to see if it can better tell the difference between glioma recurrence and progression in patients with advanced gliomas, which could help avoid unnecessary surgeries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT06444412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a history of WHO Grade 3 or 4 infiltrating glioma who have undergone first-line treatment and have MRI findings suggestive of recurrent disease.
✕Probably not a fit
Patients who have received antiangiogenic therapy or cannot undergo a PSMA PET/CT scan due to physical limitations will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of gallium-68 (Ga-68) PSMA-11 PET/CT imaging in distinguishing between glioma recurrence and progression after initial treatment. Patients with WHO Grade 3 or 4 gliomas will receive Ga-68 PSMA-11 intravenously, followed by a PET/CT scan to assess tumor activity. The study aims to improve diagnostic accuracy by correlating imaging findings with tumor pathology and treatment effects, potentially reducing the need for invasive procedures like surgery. Safety and tolerability of the imaging technique will also be evaluated.
Why it matters
Potential benefit: If successful, this imaging technique could lead to more accurate diagnoses and better treatment decisions for patients with glioma.
How similar studies have gone: Other studies have shown promise in using PSMA PET imaging for various cancers, but this specific application in glioma is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Brian J. Burkett, MD, MPH — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.