Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
March 9, 2017 updated by: H. Lee Moffitt Cancer Center and Research Institute
Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
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).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center.
- Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis.
- Location of cancer specified in the pathology report.
- Pathology reviewed by Moffitt pathologist
Exclusion Criteria:
- Less than ten biopsies obtained at time of diagnosis.
- Location of cancer not specified.
- Pathology not reviewed by Moffitt pathologist.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Pre-surgery Ultrasound
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.
|
Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.
Other Names:
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.
Other Names:
The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.
Other Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Correlation Between Ultrasound Results and Pathology Results
Time Frame: 6 months
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Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julio Pow-Sang, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2013
Primary Completion (Actual)
June 29, 2015
Study Completion (Actual)
September 18, 2015
Study Registration Dates
First Submitted
March 2, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 10, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-17294
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.