SUV on PSMA PET/CT in Non-Prostate Tumors

NCT ID: NCT03841760

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-25
• Study Completion Date: 2023-04-01

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).

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSMA PET/CT

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

Group Type: EXPERIMENTAL

PSMA PET/CT

Intervention Type: DIAGNOSTIC_TEST

For 18F-DCFPyL PET/CT: Approximately 9 mCi (333MBq) of 18F-DCFPyL is injected intravenously. Approximately 60-90 minutes following 18F-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the toes.

For 68Ga-PSMA-11 PET/CT: Approximately 2.5 MBq/kg (0.068 mCi/kg) of 68Ga-PSMA, up to a maximum of 300 MBq (8 mCi), is injected intravenously. Approximately 60 minutes following 68Ga-PSMA injection, CT and PET images are consecutively acquired from the base of the skull to toes.

Interventions

PSMA PET/CT

For 18F-DCFPyL PET/CT: Approximately 9 mCi (333MBq) of 18F-DCFPyL is injected intravenously. Approximately 60-90 minutes following 18F-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the toes.

For 68Ga-PSMA-11 PET/CT: Approximately 2.5 MBq/kg (0.068 mCi/kg) of 68Ga-PSMA, up to a maximum of 300 MBq (8 mCi), is injected intravenously. Approximately 60 minutes following 68Ga-PSMA injection, CT and PET images are consecutively acquired from the base of the skull to toes.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

PSMA PET

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stephan Probst, MD

Chief of Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2019-1531

Identifier Type: -

Identifier Source: org_study_id