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Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03077126
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 10, 2017
Last Update Posted Date March 13, 2017
Actual Study Start Date  ICMJE April 11, 2013
Actual Primary Completion Date June 29, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
Rate of Correlation Between Ultrasound Results and Pathology Results [ Time Frame: 6 months ]
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). Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.
Change History Complete list of historical versions of study NCT03077126 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer
Official Title  ICMJE Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
    Other Names:
    • ultrasound device
    • probe
  • 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.
    Other Names:
    • Aixplorer® ShearWave Elastography (SWE™)
    • ultrasound elastography
  • 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.
    Other Name: prostate surgery
Study Arms  ICMJE 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.
Interventions:
  • Other: Fleet Enema
  • Device: Aixplorer® ShearWave Elastography (SWE™)
  • Diagnostic Test: Pre-surgery Ultrasound
  • Procedure: Prostatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2017)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 18, 2015
Actual Primary Completion Date June 29, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03077126
Other Study ID Numbers  ICMJE MCC-17294
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julio Pow-Sang, M.D. H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP