Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03077126|
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Fleet Enema Device: Aixplorer® ShearWave Elastography (SWE™) Diagnostic Test: Pre-surgery Ultrasound Procedure: Prostatectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study|
|Actual Study Start Date :||April 11, 2013|
|Actual Primary Completion Date :||June 29, 2015|
|Actual Study Completion Date :||September 18, 2015|
Aixplorer® ShearWave Elastography (SWE™) Ultrasound. Participants will undergo ultrasound prep with Fleet Enema and ultrasound procedure at their pre-op visit one to two weeks before their standard of care prostatectomy.
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.
Other Name: 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.
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.
Other Name: prostate surgery
- Rate of Correlation Between Ultrasound Results and Pathology Results [ Time Frame: 6 months ]Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
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): NCT03077126
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Julio Pow-Sang, M.D.||H. Lee Moffitt Cancer Center and Research Institute|