GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 craniotomy for 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.

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-07-26
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 25
Treatments
Experimental: Diagnostic (Ga-68 PSMA-11, PET/CT)
Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov