Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01359189|
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Suspected Primary Prostate Cancer||Device: ProxiScan (scintigraphic rectal probe)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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®)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Suspected Primary Prostate Cancer
Patients with suspected prostate cancer will be evaluated for initial proof of concept and feasibility of a scintigraphic rectal probe (ProxiScanTM) utilizing a PSMA receptor radiopharmaceutical (ProstaScint®). 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. This is an exploratory, open label trial and randomization is not required. Subject blinding is not needed and investigator blinding in not possible.
Device: ProxiScan (scintigraphic rectal probe)
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."
- 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. [ Time Frame: 12 months ]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).
- TRUS, ProxiScan and SPECT/CT when compared to biopsy [ Time Frame: 12 months ]
- Estimate the sensitivity and specificity for three methods of detection: TRUS, ProxiScan and SPECT/CT when compared to biopsy.
- Estimate the sensitivity and specificity for ProxiScan and SPECT/CT when compared to PSMA IHC measurements.
- If prostatectomy histology results are available, the ability to detect areas of cancer among multiple slices of prostate tissue with TRUS, SPECT/CT and ProxiScan will be evaluated.
- Explore reclassification properties of the ProxiScan results compared to the SPECT/CT at the patient level.
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): NCT01359189
|United States, Maryland|
|Johns Hopkins Outpatient Center|
|Baltimore, Maryland, United States, 21227|
|Principal Investigator:||Steve Cho, MD||Johns Hopkins University|