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Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer

NCT ID: NCT02618200

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate cancer Computer-Aided Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3D prostate ultrasound

3D prostate ultrasound will be performed in patients the day before radical prostatectomy

Group Type EXPERIMENTAL

3D prostate ultrasound

Intervention Type DEVICE

Interventions

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3D prostate ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Edouard Herriot - Service Service de radiologie

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 37345961 (View on PubMed)

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.

Reference Type RESULT
PMID: 38493072 (View on PubMed)

Other Identifiers

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69HCL15_0100

Identifier Type: -

Identifier Source: org_study_id