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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Fleet Enema Device: Aixplorer® ShearWave Elastography (SWE™) Diagnostic Test: Pre-surgery Ultrasound Procedure: Prostatectomy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study
Actual Study Start Date : April 11, 2013
Actual Primary Completion Date : June 29, 2015
Actual Study Completion Date : September 18, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077126


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Julio Pow-Sang, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03077126     History of Changes
Other Study ID Numbers: MCC-17294
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
elastography
ultrasound
prostate
cancer screening
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases