Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Feasibility Study of Ultrasound Elastography Detecting Prostate Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077126
• Other study ID #: MCC-17294
• Status: Completed
• Phase: N/A
• First received: March 2, 2017
• Last updated: March 9, 2017
• Start date: April 11, 2013
• Est. completion date: September 18, 2015

Study information

• Verified date: March 2017
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 18, 2015
• Est. primary completion date: June 29, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

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.

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.

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Correlation Between Ultrasound Results and Pathology Results	Investigators will correlate the pathology findings from the radical prostatectomy specimen with the data recorded from USE.	6 months

External Links

•   Moffitt Cancer Center Clinical Trials website