Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer (Echo-CAD)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3D prostate ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Computer-Aided Diagnosis
Eligibility Criteria
Inclusion Criteria:
- Patient referred for radical prostatectomy
- Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
- Informed consent signed
- Patient affiliated to the French Health Insurance system
Exclusion Criteria:
- History of prostatic surgery or radiation therapy (prostatic or pelvic)
- History of hormone therapy for prostate cancer
- Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
- Patient on protection of the court, under supervision or under trusteeship
- Inability to express a consent
Sites / Locations
- Hôpital Edouard Herriot - Service Service de radiologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D prostate ultrasound
Arm Description
3D prostate ultrasound will be performed in patients the day before radical prostatectomy
Outcomes
Primary Outcome Measures
Obtention of 3D ultrasound images
Secondary Outcome Measures
Full Information
NCT ID
NCT02618200
First Posted
November 27, 2015
Last Updated
August 26, 2019
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02618200
Brief Title
Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
Acronym
Echo-CAD
Official Title
Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (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
Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.
In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Computer-Aided Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D prostate ultrasound
Arm Type
Experimental
Arm Description
3D prostate ultrasound will be performed in patients the day before radical prostatectomy
Intervention Type
Device
Intervention Name(s)
3D prostate ultrasound
Primary Outcome Measure Information:
Title
Obtention of 3D ultrasound images
Time Frame
the day before radical prostatectomy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient referred for radical prostatectomy
Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
Informed consent signed
Patient affiliated to the French Health Insurance system
Exclusion Criteria:
History of prostatic surgery or radiation therapy (prostatic or pelvic)
History of hormone therapy for prostate cancer
Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
Patient on protection of the court, under supervision or under trusteeship
Inability to express a consent
Facility Information:
Facility Name
Hôpital Edouard Herriot - Service Service de radiologie
City
LYON cedex 03
ZIP/Postal Code
69437
Country
France
12. IPD Sharing Statement
Learn more about this trial
Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
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