SUV on PSMA PET/CT in Non-Prostate Tumors

NCT03841760 | Terminated Phase 2

• 1 other identifier: 2019-1531
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Confirm PSMA PET uptake in tumors studied

  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.

  Immediate

Study Arms (1)

PSMA PET/CT

EXPERIMENTAL

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

Diagnostic Test: PSMA PET/CT

Interventions

PSMA PET/CT 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.

Also known as: PSMA PET

PSMA PET/CT

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: July 25, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CA (1)