NCT03077126

Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The point estimate and its 95% confidence interval will be calculated using the exact binominal method. Identification of suspicious cancer tissue in a 12 prostate zone schema: Participants will undergo USE: Aixplorer® ShearWave Elastography (SWE™), (SuperSonic Imagine). Areas of the prostate with high suspicion for harboring cancer will be recorded in a 12 zone prostate schema. For study purposes the prostate will be divided into Zone 1(Left Lateral Base), Zone 2 (Left Base), Zone 3 (Right Base), Zone 4 (Right Lateral Base), Zone 5 (Left Lateral Mid), Zone 6 (Left Mid), Zone 7 (Right Mide), Zone 8 (Right Lateral Mid), Zone 9 (Left Lateral Apex), Zone 10 (Left Apex), Zone 11 (Right Apex), Zone 12 (Right Lateral Apex).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-11
• Primary completion: 2015-06-29
• Completion: 2015-09-18
• First posted: 2017-03-10
• Last updated: 2017-03-13

Locations

1 site across 1 country: United States