Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02307552|
Recruitment Status : Terminated (The probe could not be anchored in place and would rotate about its axis, thus comparison was difficult.)
First Posted : December 4, 2014
Results First Posted : June 27, 2017
Last Update Posted : July 27, 2017
This study is being performed to verify the ability to use minimally invasive transurethral ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral ultrasonic prostate imaging, may in the future, be used for detection and monitoring these disease processes to minimize the need for obtaining surgical biopsy specimens. The hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging, results in unique image signatures for identification of prostate cancer. This imaging procedure provides a multifaceted view of the entire in-situ gland.
The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence of cancer in the prostate gland requires interpretation and has a good but limited to predict prostate cancer on biopsy, with significant false prediction rates. More importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the prostate gland. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: UreScan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||May 2014|
Experimental: All patients
All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.
The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.
- Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer [ Time Frame: one year ]The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis
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): NCT02307552
|United States, California|
|University of California, Irvine Health|
|Orange, California, United States, 92868|
|Principal Investigator:||Thomas E Ahlering, MD||University of California, Irvine|