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Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

NCT02307552 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-07-27

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

UreScan

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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Thomas E Ahlering, MD · University of California, Irvine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307552 on ClinicalTrials.gov