Back to resultsAssessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci (PROSTATE SSI)
Primary Purpose
Cancer of Prostate
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer of Prostate focused on measuring prostate cancer, elastography, elasticity
Eligibility Criteria
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
Sites / Locations
- Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elastography
Arm Description
Outcomes
Primary Outcome Measures
Young's modulus(kPa) of cancerous tumor foci
Young's modulus(kPa) of normal peripheral zone
Young's modulus(kPa) of normal transition zone
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01639859
Brief Title
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci
Acronym
PROSTATE SSI
Official Title
Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Prostate
Keywords
prostate cancer, elastography, elasticity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elastography
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Elastography
Other Intervention Name(s)
Supersonic Imagine Aixplorer scanner
Intervention Description
The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.
Primary Outcome Measure Information:
Title
Young's modulus(kPa) of cancerous tumor foci
Time Frame
2 years
Title
Young's modulus(kPa) of normal peripheral zone
Time Frame
2 years
Title
Young's modulus(kPa) of normal transition zone
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROUVIERE Olivier, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69 437
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27553936
Citation
Rouviere O, Melodelima C, Hoang Dinh A, Bratan F, Pagnoux G, Sanzalone T, Crouzet S, Colombel M, Mege-Lechevallier F, Souchon R. Stiffness of benign and malignant prostate tissue measured by shear-wave elastography: a preliminary study. Eur Radiol. 2017 May;27(5):1858-1866. doi: 10.1007/s00330-016-4534-9. Epub 2016 Aug 23.
Results Reference
result
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Assessment of Supersonic Imagine Aixplorer for the Detection and Localisation of Prostate Cancer Foci
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