68Ga-PSMA (ProstaMedix™) PET-CT Scan for Diagnosis and Management of Prostate Cancer

Ebrahim Delpassand1 site in 1 country208 target enrollmentMay 2015

ConditionsProstate Cancer

Interventions68Ga-PSMA

Drugs68Ga-PSMA

Overview

Phase: Phase 2
Intervention: 68Ga-PSMA
Conditions: Prostate Cancer
Sponsor: Ebrahim Delpassand
Enrollment: 208
Locations: 1
Primary Endpoint: The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.

Detailed Description

68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body. A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Ebrahim Delpassand

Responsible Party

Sponsor Investigator

Principal Investigator

Ebrahim Delpassand

Chairman and Medical Director

Radio Isotope Therapy of America

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

68Ga-PSMA

Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.

Intervention: 68Ga-PSMA

Outcomes

Primary Outcomes

The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.

Time Frame: 12 months

The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.