Informations générales (source: ClinicalTrials.gov)
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System (CHANGE)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
avril 2021
juin 2026
29 juin 2024
Multiparametric MRI of the prostate is recommended before each prostate biopsy. It
identifies suspicious areas which will then be the subject of targeted biopsies. However,
MRI suffers from low specificity and moderate inter-reader reproducibility, including
with the use of the PI-RADS version 2.1 score.
We are developing, within the framework of RHU PERFUSE, a computer-aided diagnosis system
(CAD) for the detection of ISUP ≥2 cancers. This system has been trained on a database of
patients who had prostate MRI and prostatectomy at the Hospices Civils de Lyon and
performed well on a database of patients who had prostate MRI before biopsy at the
Hopices civils de Lyon.
However, one of the weaknesses of artificial intelligence systems is their low robustness
when tested on MRI images from different manufacturers or institutions.
The goal of the CHANGE study is to build a prospective multicenter cohort of patients who
underwent prostate multiparametric MRI followed by systematic and targeted prostate
biopsies. The cohort will be used for the final external validation of the CAD developed
in PERFUSE.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Necker-Enfants Malades | jean-michel correas, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse - 231059 - Toulouse - France | aziza richard, MD | Contact (sur clinicalTrials) | |||
| Department of radiology and urology, CHU de Lille - 59037 - Lille - France | Philippe Puech, Pr | Contact (sur clinicalTrials) | |||
| Department of radiology and urology, CHU Pellegrin - 33076 - Bordeaux - France | Clément Marcellin, Dr | Contact (sur clinicalTrials) | |||
| Department of radiology and urology, Hôpital Edouard Herriot - 69003 - Lyon - France | Olivier Rouvière, Pr | Contact (sur clinicalTrials) | |||
| Department of Radiology and Urology, Hopital Européen Marseille - 13003 - Marseille - France | Marc André, MD | Contact (sur clinicalTrials) | |||
| Department of radiology and urology, Hôpital la Pitié Salpêtrière - 75013 - Paris - France | Raphaele renardpenna, Pr | Contact (sur clinicalTrials) | |||
| Department of radiology and urology, Hôpital Saint Joseph Saint Luc - 69007 - Lyon - France | Favie Bratan, MD | Contact (sur clinicalTrials) | |||
| Department of Radiology and Urology, Institut Paoli-Calmettes Marseille - 13273 - Marseille - France | Serge Brunelle, MD | Contact (sur clinicalTrials) | |||
| Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg - 67000 - Strasbourg - France | Catherine Roy, Pr | Contact (sur clinicalTrials) | |||
| Department of urology and Radiology - 34090 - Montpellier - France | Ingrid Millet, Pr | Contact (sur clinicalTrials) | |||
| Department of urology and radiology, CHLS - 69310 - Pierre-Bénite - France | Paul Moldovan, MD | Contact (sur clinicalTrials) | |||
| Department of urology and Radiology, CHU Grenoble Alpes - 38043 - Grenoble - France | Bénedicte Guillaume, Dr | Contact (sur clinicalTrials) | |||
| Department of urology, CHU de Saint-Étienne Hôpital Nord - 42055 - Saint-Etienne - France | Nicolas Mottet-Auselot, Pr | Contact (sur clinicalTrials) | |||
| Department of Urology, Clinique Beausoleil Montpellier - 34070 - Montpellier - France | Grégoire Poinas, Dr | Contact (sur clinicalTrials) | |||
| Department of Urology, Quint Fonsegrives - 31130 - Quint Fonsegrives - France | Guillaume Ploussard, MD/PhD | Contact (sur clinicalTrials) | |||
| Department Urology, Clinique urologique Nantes Atlantis - 44800 - Nantes - France | Eric Potiron, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Men over 18 years of age
- Patient with clinical suspicion of prostate cancer referred for a multiparametric
MRI of the prostate before a first series of biopsies or before new biopsies after
one or more series of negative biopsies
- PSA ≤ 30 ng / ml
- Clinical stage ≤ T2c
- Affiliation or beneficiary of a social security scheme
- Men over 18 years of age
- Patient with clinical suspicion of prostate cancer referred for a multiparametric
MRI of the prostate before a first series of biopsies or before new biopsies after
one or more series of negative biopsies
- PSA ≤ 30 ng / ml
- Clinical stage ≤ T2c
- Affiliation or beneficiary of a social security scheme
- Men over 80 years of age
- PSA> 30 ng / ml
- Stage T3 or T4 on digital rectal examination
- Previous prostate biopsy performed within 12 months
- History of prostate cancer diagnosed by biopsy or endourethral resection.
- History of pelvic radiotherapy regardless of the cause.
- History of total or focal treatment for prostate cancer.
- History of hormone therapy
- MRI performed more than 3 months before biopsy
- Prostate MRI performed on a machine other than the center's machines accredited for
the study.
- Presence of a hip prosthesis
- Contraindication to performing an MRI
- Contraindication to performing prostate biopsy
- Patient subject to a legal protection measure or deprived of liberty
- Subject participating or having participated in interventional medical research with
an exclusion period still in progress
- Misunderstanding of the French language