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SUV on PSMA PET/CT in Non-Prostate Tumors

S

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase

Terminated
Phase 2

Conditions

Cancer

Treatments

Diagnostic Test: PSMA PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT03841760
2019-1531

Details and patient eligibility

About

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.

Full 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).

Enrollment

3 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

PSMA PET/CT
Experimental group
Description:
One (1) PSMA PET/CT scan with with either PSMA-11 or DCFPyL
Treatment:
Diagnostic Test: PSMA PET/CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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