Using 68Ga-PSMA-11 PET scans to assess brain tumors
An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET
EARLY_PHASE1 · Memorial Sloan Kettering Cancer Center · NCT06209567
This study is testing if a special type of PET scan can help doctors see how active brain tumors are in adults with high-grade glioma or brain metastases.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center (other) |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06209567 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Ga-PSMA-11 PET/CT scans in measuring tumor activity in adults with high-grade glioma or brain metastases. Participants must be 18 years or older and have confirmed cases of these conditions, with lesions suitable for biopsy. The study aims to improve the understanding of tumor uptake in cancerous tissues, which could enhance treatment planning and outcomes. The intervention involves administering the PET scans to assess the tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed high-grade glioma or brain metastases who are scheduled for biopsy or resection.
Not a fit: Patients who cannot undergo a PET scan due to medical conditions or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better assessment and management of brain tumors, improving patient outcomes.
How similar studies have performed: Other studies using PET scans for tumor assessment have shown promise, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (RECRUITING)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States (RECRUITING)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (RECRUITING)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Anton Nosov, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Anton Nosov, MD
- Email: nosova@mskcc.org
- Phone: 212-639-8575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High-grade Glioma, Brain Metastases, Brain Metastases, Adult, 68Ga-PSMA-11, 23-382, Memorial Sloan Kettering Cancer Center