Clinical trial NCT06209567: A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
Official title: An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: High-grade Glioma
Brain Metastases
Brain Metastases, Adult
Keywords: 68Ga-PSMA-11
High-grade Glioma
Brain Metastases
23-382
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Assess range of tumor uptake of 68Ga-PSMA-11 in participants
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anton Nosov, MD
role: PRINCIPAL_INVESTIGATOR
References: