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

Brain Metastases Clinical Trial

Official title:

An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209567
• Other study ID #: 23-382
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 5, 2024
• Est. completion date: January 5, 2027

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Simone Krebs, MD
• Phone: 212-639-7998
• Email: krebss[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 5, 2027
• Est. primary completion date: January 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Metastases, Adult
• Brain Neoplasms
• Glioma
• High-grade Glioma
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Consent only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent Only)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess range of tumor uptake of 68Ga-PSMA-11 in participants	Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax	up to 12 months

External Links

•   Memorial Sloan Kettering Cancer Center