Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
Condition: Suspected Primary Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      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.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.
    

Detailed description: 
      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.
    

Intervention name(s): ProxiScan (scintigraphic rectal probe)
Intervention type(s): Device
Intervention description(s): ProxiScanTM is a compact, high-resolution gamma camera which has been developed for the detection of cancer and other abnormalities in the body by imaging the distribution of radionuclides in the human body using planar imaging techniques. This camera is capable of high-performance imaging of radiopharmaceuticals distributed within anatomical regions of interest located close to the camera head. The ProxiScan compact scintigraphic detector was approved by the FDA to market the device for the following indication: "The ProxiScanTM is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScanTM may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used."
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Suspected Primary Prostate Cancer