NCT06444412

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
27mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

May 31, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

May 31, 2024

Last Update Submit

January 12, 2026

Conditions

WHO Grade 3 GliomaWHO Grade 4 Glioma

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 24 hours after 68Ga-PSMA-11 injection

  • 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.

    Up to 60 days

Study Arms (1)

Diagnostic (Ga-68 PSMA-11, PET/CT)

EXPERIMENTAL

Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.

Procedure: Computed TomographyOther: Electronic Health Record ReviewDrug: Ga 68 PSMA-11Procedure: Positron Emission Tomography

Interventions

Ga 68 PSMA-11DRUG

Contrast dye given IV

Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-DKFZ-PSMA-11, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA, 68Ga-PSMA-11, 68Ga-PSMA-HBED-CC, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, AAA 517, AAA-517, AAA517, Ga PSMA, Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled PSMA-11, Ga 68 PSMA-11, Intravenous Solution, Gallium Ga 68 PSMA-11, Gallium Ga 68-labeled PSMA-11, Gallium-68 PSMA, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, GaPSMA, PSMA-HBED-CC GA-68
Diagnostic (Ga-68 PSMA-11, PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Diagnostic (Ga-68 PSMA-11, PET/CT)
Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
Diagnostic (Ga-68 PSMA-11, PET/CT)
Electronic Health Record ReviewOTHER

Ancillary studies

Diagnostic (Ga-68 PSMA-11, PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Interventions

gallium 68 PSMA-1168Ga-DKFZ-PSMA-11Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Brian J. Burkett, MD, MPH

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 5, 2024

Study Start

January 12, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

US(1)