Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci (PROSTATE SSI)

May 23, 2019 updated by: Hospices Civils de Lyon
The primary aim of the study is to assess the elasticity (Young's modulus) of cancerous tumor foci, of normal peripheral zone, and of normal transition zone in the prostate. Images obtained with the Supersonic Imagine Aixplorer scanner prior to radical prostatectomy are compared to whole-mount histology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • France
      • Lyon, France, 69 437
        • Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot

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:

  • Patient over 18 years old, with prostate cancer and scheduled for radical prostatectomy

Exclusion Criteria:

  • Medical history of prostate surgery or radiotherapy of prostate
  • Medical history of abdominal perinéanal amputation or whole of state which prevent to use endorectal probe

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Elastography
Other: Elastography
The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.
Other Names:
  • Supersonic Imagine Aixplorer scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Young's modulus(kPa) of cancerous tumor foci
Time Frame: 2 years
2 years
Young's modulus(kPa) of normal peripheral zone
Time Frame: 2 years
2 years
Young's modulus(kPa) of normal transition zone
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: ROUVIERE Olivier, Pr, Hospices Civils de Lyon

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.

General Publications

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

October 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

June 22, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (ESTIMATE)

July 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.658

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.

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