- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02618200
Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer (Echo-CAD)
Creation of a Multimodality Image Database (MRI + Ultrasound) for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lyon, France, 69437
- Hôpital Edouard Herriot - Service Service de radiologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 3D prostate ultrasound
3D prostate ultrasound will be performed in patients the day before radical prostatectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Obtention of 3D ultrasound images
Time Frame: the day before radical prostatectomy
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the day before radical prostatectomy
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jaouen T, Souchon R, Moldovan PC, Bratan F, Duran A, Hoang-Dinh A, Di Franco F, Debeer S, Dubreuil-Chambardel M, Arfi N, Ruffion A, Colombel M, Crouzet S, Gonindard-Melodelima C, Rouviere O. Characterization of high-grade prostate cancer at multiparametric MRI using a radiomic-based computer-aided diagnosis system as standalone and second reader. Diagn Interv Imaging. 2023 Oct;104(10):465-476. doi: 10.1016/j.diii.2023.04.006. Epub 2023 May 20.
- Couchoux T, Jaouen T, Melodelima-Gonindard C, Baseilhac P, Branchu A, Arfi N, Aziza R, Barry Delongchamps N, Bladou F, Bratan F, Brunelle S, Colin P, Correas JM, Cornud F, Descotes JL, Eschwege P, Fiard G, Guillaume B, Grange R, Grenier N, Lang H, Lefevre F, Malavaud B, Marcelin C, Moldovan PC, Mottet N, Mozer P, Potiron E, Portalez D, Puech P, Renard-Penna R, Roumiguie M, Roy C, Timsit MO, Tricard T, Villers A, Walz J, Debeer S, Mansuy A, Mege-Lechevallier F, Decaussin-Petrucci M, Badet L, Colombel M, Ruffion A, Crouzet S, Rabilloud M, Souchon R, Rouviere O. Performance of a Region of Interest-based Algorithm in Diagnosing International Society of Urological Pathology Grade Group >/=2 Prostate Cancer on the MRI-FIRST Database-CAD-FIRST Study. Eur Urol Oncol. 2024 Oct;7(5):1113-1122. doi: 10.1016/j.euo.2024.03.003. Epub 2024 Mar 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL15_0100
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