Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
NCT ID: NCT03077126
Last Updated: 2017-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2013-04-11
2015-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Location of cancer not specified.
* Pathology not reviewed by Moffitt pathologist.
18 Years
MALE
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Julio Pow-Sang, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-17294
Identifier Type: -
Identifier Source: org_study_id
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