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Clinical Trials/NCT03841760
NCT03841760
Terminated
Phase 2

SUV on PSMA PET/CT in Non-Prostate Tumors

Sir Mortimer B. Davis - Jewish General Hospital1 site in 1 country3 target enrollmentJuly 25, 2019
ConditionsCancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cancer
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Enrollment
3
Locations
1
Primary Endpoint
Confirm PSMA PET uptake in tumors studied
Status
Terminated
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 25, 2019
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Stephan Probst, MD

Chief of Nuclear Medicine

Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Confirm PSMA PET uptake in tumors studied

Time Frame: 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.

Study Sites (1)

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