SUV on PSMA PET/CT in Non-Prostate Tumors

Phase 2

Terminated

• Conditions: Cancer
• Interventions: Diagnostic Test: PSMA PET/CT

• Registration Number: NCT03841760
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary

The objective of this pilot study is to evaluate if 18F-DCFPyL PET/CT or 68Ga-PSMA-11 PET/CT can be used for detection and staging of PSMA-expressing non-prostate tumor.

Detailed Description

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is over-expressed many fold on prostate cancer cells and other types of cancer. Since PSMA is a new target for molecular therapy, PSMA PET/CT allows assessment for therapy in addition to characterization of tumors and staging. Given the success of PSMA PET/CT for prostate cancer and the increasing number of case reports on PSMA uptake in non-prostate cancer, the aim of this project is to fill this literature gap by documenting the avidity of tumors (by means of SUVmax) based on their PSMA immunostaining (by the pathologist) or based on literature report (peer-reviewed article confirming PSMA expression in a tumor type).

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-07-25
• Status Verified: 2023-04
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Age 18 years or older, able to understand and provide written informed consent
• The patient has a tumor known or suspected to have PSMA expression, as reported in the literature or by positive histopathological staining for PSMA.
• The known or suspected tumor must fall into one of the following categories: carcinoma, sarcoma, or hematologic cancer.
• ECOG performance status 0 - 3, inclusive
• Under referring physician's care
• Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation

Exclusion Criteria

• Patients with neoplasm known in literature to not have PSMA expression, unless patient specific tissue sampling shows PSMA staining on histopathology.
• Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
• Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
• Patients with unmanageable claustrophobia
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSMA PET/CT	PSMA PET/CT	One (1) PSMA PET/CT scan with with either PSMA-11 or DCFPyL

Primary Outcome Measures

Name	Time	Method
Confirm PSMA PET uptake in tumors studied	Immediate	1. To confirm 18F-DCFPyL PET/CT or 68Ga-PSMA-11 uptake in the known tumor or other lesions found on PSMA PET/CT. The threshold for a positive lesion is a semi-quantitative measurement of activity: SUVmax \> 4 in lesions larger than 1.5 cm (so as to offset PET partial volume effect or "camera limitations"). IF SUVmax \> 4, the tumor is positive for PSMA PET/CT; If not, the tumor is negative for PSMA PET/CT.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada