MedTrace Logo

Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

NCT03077126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-03-13

No results posted yet for this study

Summary

The main purpose of this study is to determine the accuracy and feasibility (possibility) of Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.) for detecting prostate cancer in men undergoing radical prostatectomy.

Conditions

Interventions

OTHER

Fleet Enema

Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.

DEVICE

Aixplorer® ShearWave Elastography (SWE™)

Pre-surgery ultrasound: Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.). The device is used transrectally. This device (ultrasound system) has been cleared by the United States Food and Drug Administration (FDA) for the indication for use as described in this consent form.

DIAGNOSTIC_TEST

Pre-surgery Ultrasound

The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.

PROCEDURE

Prostatectomy

Participants will undergo radical prostatectomy as currently performed at our Moffitt Cancer Center. This procedure is performed under general anesthesia in the operating room. This is considered standard of care.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Julio Pow-Sang, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-11
Primary Completion
2015-06-29
Completion
2015-09-18

Countries

  • United States

Study Locations

More Related Trials

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 NCT03077126 on ClinicalTrials.gov