Spots Global Cancer Trial Database for Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
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Trial Identification
Brief Title: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Official Title: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
Study ID: NCT03077126
Conditions
Study Description
Brief 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Contact Details
Name: Julio Pow-Sang, M.D.
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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