Clinical trial · Interventional
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
GA-68 PSMA-11 PET To Evaluate Malignant Glioma Recurrence - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| WHO Grade 3 Glioma | WHO Grade 3 Glioma | ONTOLOGY_EXACT | 0.98 |
| WHO Grade 4 Glioma | WHO Grade 4 Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Ga 68 PSMA-11 | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (Ga-68 PSMA-11, PET/CT)
- description
- Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.
- interventionNames
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
- Drug: Ga 68 PSMA-11
- Procedure: Positron Emission Tomography
Primary outcomes (2)
- measure
- Adverse Events (safety and tolerability)
- timeFrame
- Up to 24 hours after 68Ga-PSMA-11 injection
- description
- 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.
- measure
- Tolerability of PSMA positron emission tomography scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available