Initial Exploratory Evaluation of a Transrectal Scintigraphic Detector (ProxiScanTM) for Detection of Primary Prostate Cancer Utilizing a Prostate Specific Membrane Antigen (PSMA) Based Radiotracer (ProstaScint®)
This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe
scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent
(ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small
cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal
ultrasound (TRUS) developed by Hybridyne Imaging Technologies, Inc. Due to its inherent
small size, this camera is capable of potentially imaging of prostate cancer specific
radiopharmaceutical uptake distributed within the prostate gland located closely adjacent to
the camera head.In this study the investigators will enroll patients with a clinical
suspicion and high likelihood of prostate cancer. A scintigraphic rectal probe
(ProxiScanTM) will be used to detect ProstaScint® uptake in the prostate gland, in
comparison to TRUS and pelvis planar and SPECT/CT. The incidence of biopsy positive prostate
cancer in patients with suspected disease clinically can range from 25% to 40%; therefore up
to 12 patients will be enrolled on this study. To explore the adjunctive
benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland
utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as
normal controls. Prostate cancer sextant biopsy histology results will be correlated with
ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe
and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific
ProstaScint® uptake in primary prostate cancer.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the feasibility of a Transrectal Scintigraphic Detector (ProxiScanTM) to detect and localize prostate specific membrane antigen (ProstaScint®) radiotracer uptake in suspected primary prostate cancer patients.
The proximity of the placement of the ProxiScanTM device to the prostate should result in an improvement in the sensitivity and specificity for detection of prostate cancer specific radiopharmaceutical detection. The primary objectives will be evaluated at the patient level, while secondary objectives will be analyzed based on data and outcomes measured by region of the prostate (sextant).
12 months
Yes
Steve Cho, MD
Principal Investigator
Johns Hopkins University
United States: Food and Drug Administration
J1050
NCT01359189
May 2011
September 2014
Name | Location |
---|---|
Johns Hopkins Outpatient Center | Baltimore, Maryland 21287 |