A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06209567
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Simone Krebs, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	High-grade Glioma, Brain Metastases, Brain Metastases, Adult
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Participants with high-grade glioma

Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases

Interventions

Diagnostic Test: - 68Ga-PSMA-11 PET Scans

Participants will be injected intravenously with 68Ga-PSMA-11 via intravenous catheter. PET scans will first be interpreted without information on the results of other imaging modalities. Following the blinded read of the 68Ga-PSMA-11 PET scans, all recorded findings will be correlated with the results of CE CT and MR studies and 18F-FDG PET/CT or PET/MR performed as part of standard clinical care.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920

Site Contact

Simone Krebs, MD

[email protected]

212-639-7998

Middletown, New Jersey

Status