Spots Global Cancer Trial Database for Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
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Trial Identification
Brief Title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Official Title: Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Study ID: NCT04732156
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Department of radiology and urology, CHU Pellegrin, Bordeaux, , France
Department of urology and Radiology, CHU Grenoble Alpes, Grenoble, , France
Department of radiology and urology, CHU de Lille, Lille, , France
Department of radiology and urology, Hôpital Edouard Herriot, Lyon, , France
Department of radiology and urology, Hôpital Saint Joseph Saint Luc, Lyon, , France
Department of Radiology and Urology, Hopital Européen Marseille, Marseille, , France
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille, Marseille, , France
Department of Urology, Clinique Beausoleil Montpellier, Montpellier, , France
Department of urology and Radiology, Montpellier, , France
Department Urology, Clinique urologique Nantes Atlantis, Nantes, , France
Department of radiology and urology, Hôpital la Pitié Salpêtrière, Paris, , France
Department of radiology, Hôpital Necker, Paris, , France
Department of urology and radiology, CHLS, Pierre-Bénite, , France
Department of Urology, Quint Fonsegrives, Quint Fonsegrives, , France
Department of urology, CHU de Saint-Étienne Hôpital Nord, Saint-Etienne, , France
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg, Strasbourg, , France
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse, Toulouse, , France
Contact Details
Name: Olivier ROUVIERE, Pr
Affiliation: Service d'imagerie, pavillon B Hôpital Edouard Herriot
Role: PRINCIPAL_INVESTIGATOR
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