Clinical trial · Interventional
A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET
NCT06209567CI-TRIAL-00098327active not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Brain Metastases, Adult | — | UNRESOLVED | — |
| High-grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 PET Scans | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with high-grade glioma
- description
- Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases
- interventionNames
- Diagnostic Test: 68Ga-PSMA-11 PET Scans
Primary outcomes (1)
- measure
- Assess range of tumor uptake of 68Ga-PSMA-11 in participants
- timeFrame
- up to 12 months
- description
- Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to sign (or their legally acceptable representative (LAR) must sign) a written informed consent document * Adults ≥ 18 years old * Suspicion for or histologically or cytologically confirmed and previously treated HGG or brain metastases from a primary extracranial malignancy * Lesion size ≥ 1 cm (for the lesion to be biopsied) * ECOG performance status ≤ 2 (Karnofsky ≥ 60%) * Planned to undergo biopsy/resection of brain lesion Exclusion Criteria: * Inability to undergo a PET scan (e.g., claustrophobia or noncompatible implant in case PET/MR is performed) * Pregnant or nursing female. All women of childbearing potential must have a documented negative serum or urine pregnancy test \<1 week before study. * Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients with severe allergy to both iodinated and gadolinium contrast.
References
Publications (0)
Data not yet available
No reference posted for this study.