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SUV on PSMA PET/CT in Non-Prostate Tumors

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ClinicalTrials.gov Identifier: NCT03841760
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2019
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Stephan Probst, MD, 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.

Condition or disease Intervention/treatment Phase
Cancer Diagnostic Test: PSMA PET/CT Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SUV on PSMA PET/CT in Non-Prostate Tumors
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Arm Intervention/treatment
Experimental: PSMA PET/CT
One (1) PSMA PET/CT scan with with either PSMA-11 or DCFPyL
Diagnostic Test: 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.

Other Name: PSMA PET




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841760


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
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Responsible Party: Stephan Probst, MD, Chief of Nuclear Medicine, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03841760    
Other Study ID Numbers: 2019-1531
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No