search
Back to results

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System (CHANGE)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Follow up questionnaire
Human reading of prostate MR images (PI-RADSv2.1).
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of radiology and urology, CHU Pellegrin
  • Department of urology and Radiology, CHU Grenoble Alpes
  • Department of radiology and urology, CHU de Lille
  • Department of radiology and urology, Hôpital Edouard HerriotRecruiting
  • Department of radiology and urology, Hôpital Saint Joseph Saint Luc
  • Department of Radiology and Urology, Hopital Européen Marseille
  • Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
  • Department of Urology, Clinique Beausoleil Montpellier
  • Department of urology and Radiology
  • Department Urology, Clinique urologique Nantes Atlantis
  • Department of radiology and urology, Hôpital la Pitié Salpêtrière
  • Department of radiology, Hôpital Necker
  • Department of urology and radiology, CHLS
  • Department of Urology, Quint Fonsegrives
  • Department of urology, CHU de Saint-Étienne Hôpital Nord
  • Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
  • Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prospective multicenter cohort

Arm Description

Constitution of a prospective multicenter cohort of 420 patients with suspected prostate cancer that will undergo prostate multiparametric MRI followed by systematic and targeted biopsy. When available (i.e., at the end of the RHU PERFUSE program, November 2022), the final version of the CAD will be used retrospectively to assess the risk that the prostate/targeted lesions harbor ISUP ≥2 cancer. In addition, a blood sample will be taken in all patients before the biopsy to assess the performance of the PHI index in predicting the presence of ISUP ≥2 cancer at systematic and targeted biopsy (ancillary study, secondary objective).

Outcomes

Primary Outcome Measures

Evaluation of the non-inferiority of the AUC of the final CAD developed in the PERFUSE program for the detection of ISUP ≥2 cancers, as compared to that of the PI-RADSv2.1 score (human reading), at per-patient analysis.
AUC of the final CAD and of the PI-RADS version 2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI, at per-patient analysis. A priori-defined non-inferiority margin: 5 percentage points.

Secondary Outcome Measures

Comparison of the specificities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis.
Specificity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis).
Comparison of the sensitivities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis .
Sensitivity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis)
Comparison of the AUCs of the final CAD and of the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
AUC of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.
Comparison of the sensitivities and specificities of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
Sensitivity and specificity of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.
Assessment of the impact of biopsy setting, magnetic field strength, human reader's experience, biopsy guidance technique and prostate volume on the AUC of the CAD and the PI-RADSv2.1 scores for the detection of ISUP cancers ≥2, at per-patient analysis.
Analysis of the effect of biopsy setting, magnetic field strength, reader's experience, biopsy guidance technique and prostate volume on the AUC of the final CAD and the PI-RADv2.1, at per-patient analysis.
Comparison of the AUC of the PHI index to that of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers, at per-patient analysis.
AUC of the PHI index for the detection of cancers ISUP ≥2 on systematic and targeted biopsies performed after MRI, at per-patient analysis.
Estimation of the number of biopsies avoided and the number of ISUP cancers ≥2 missed for the following diagnostic strategies:
Number of biopsies avoided and number of ISUP cancers ≥2 missed according to the strategies described below: PHI index then, if positive, MRI and biopsies regardless of the MRI result (MRI used only to guide targeted biopsies). PHI index then, if positive, MRI then, if positive, targeted biopsies. Biopsy only if MRI positive; no PHI index. MRI then, if positive, PHI index then, if positive, targeted biopsies. MRI then, if negative, PHI index; biopsy for patients with a positive MRI or with a negative MRI but a positive PHI index PHI index and MRI for all patients; biopsy if positive PHI index AND positive MRI. PHI index and MRI for all patients; biopsy if positive PHI OR positive MRI.

Full Information

First Posted
January 18, 2021
Last Updated
December 8, 2021
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT04732156
Brief Title
Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System
Acronym
CHANGE
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 Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
June 15, 2026 (Anticipated)
Study Completion Date
June 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, MRI, Artificial Intelligence, Computer-aided diagnosis system, Prostate biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective multicenter cohort
Arm Type
Other
Arm Description
Constitution of a prospective multicenter cohort of 420 patients with suspected prostate cancer that will undergo prostate multiparametric MRI followed by systematic and targeted biopsy. When available (i.e., at the end of the RHU PERFUSE program, November 2022), the final version of the CAD will be used retrospectively to assess the risk that the prostate/targeted lesions harbor ISUP ≥2 cancer. In addition, a blood sample will be taken in all patients before the biopsy to assess the performance of the PHI index in predicting the presence of ISUP ≥2 cancer at systematic and targeted biopsy (ancillary study, secondary objective).
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Measurement of PHI Index
Intervention Type
Other
Intervention Name(s)
Follow up questionnaire
Intervention Description
3 years after inclusion
Intervention Type
Diagnostic Test
Intervention Name(s)
Human reading of prostate MR images (PI-RADSv2.1).
Intervention Description
The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)
Primary Outcome Measure Information:
Title
Evaluation of the non-inferiority of the AUC of the final CAD developed in the PERFUSE program for the detection of ISUP ≥2 cancers, as compared to that of the PI-RADSv2.1 score (human reading), at per-patient analysis.
Description
AUC of the final CAD and of the PI-RADS version 2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI, at per-patient analysis. A priori-defined non-inferiority margin: 5 percentage points.
Time Frame
Through recruitment completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Comparison of the specificities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis.
Description
Specificity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis).
Time Frame
Through recruitment completion, an average of 2 years
Title
Comparison of the sensitivities of the CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers at per-patient, per-lobe and per-lesion analysis .
Description
Sensitivity of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers on systematic and targeted biopsies performed after MRI (per-patient, per-lobe and per-lesion analysis)
Time Frame
Through recruitment completion, an average of 2 years
Title
Comparison of the AUCs of the final CAD and of the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
Description
AUC of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.
Time Frame
Through recruitment completion, an average of 2 years
Title
Comparison of the sensitivities and specificities of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years, at per-patient analysis.
Description
Sensitivity and specificity of the final CAD and the PI-RADSv2.1 score for predicting the diagnosis of ISUP ≥2 cancer within 3 years of follow-up, at per-patient analysis.
Time Frame
Through study completion, an average of 5 years
Title
Assessment of the impact of biopsy setting, magnetic field strength, human reader's experience, biopsy guidance technique and prostate volume on the AUC of the CAD and the PI-RADSv2.1 scores for the detection of ISUP cancers ≥2, at per-patient analysis.
Description
Analysis of the effect of biopsy setting, magnetic field strength, reader's experience, biopsy guidance technique and prostate volume on the AUC of the final CAD and the PI-RADv2.1, at per-patient analysis.
Time Frame
Through recruitment completion, an average of 2 years
Title
Comparison of the AUC of the PHI index to that of the final CAD and of the PI-RADSv2.1 score for the detection of ISUP ≥2 cancers, at per-patient analysis.
Description
AUC of the PHI index for the detection of cancers ISUP ≥2 on systematic and targeted biopsies performed after MRI, at per-patient analysis.
Time Frame
Through recruitment completion, an average of 2 years
Title
Estimation of the number of biopsies avoided and the number of ISUP cancers ≥2 missed for the following diagnostic strategies:
Description
Number of biopsies avoided and number of ISUP cancers ≥2 missed according to the strategies described below: PHI index then, if positive, MRI and biopsies regardless of the MRI result (MRI used only to guide targeted biopsies). PHI index then, if positive, MRI then, if positive, targeted biopsies. Biopsy only if MRI positive; no PHI index. MRI then, if positive, PHI index then, if positive, targeted biopsies. MRI then, if negative, PHI index; biopsy for patients with a positive MRI or with a negative MRI but a positive PHI index PHI index and MRI for all patients; biopsy if positive PHI index AND positive MRI. PHI index and MRI for all patients; biopsy if positive PHI OR positive MRI.
Time Frame
Through recruitment completion, an average of 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier ROUVIERE, Pr
Phone
4 72 11 61 70
Ext
+33
Email
olivier.rouviere@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline MANSUY, PhD
Phone
4 72 11 51 70
Ext
+33
Email
adeline.mansuy@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier ROUVIERE, Pr
Organizational Affiliation
Service d'imagerie, pavillon B Hôpital Edouard Herriot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of radiology and urology, CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément Marcellin, Dr
Phone
5 56 79 55 99
Ext
+33
Email
clement.marcelin@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Franck Bladou, Pr
Facility Name
Department of urology and Radiology, CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénedicte Guillaume, Dr
Phone
4 76767984
Ext
+33
Email
bguillaume@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Gaelle Fiard, MD
Facility Name
Department of radiology and urology, CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Puech, Pr
Phone
3 20 44 61 91
Ext
+33
Email
philippe.puech@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Arnauld Villers, Pr
Facility Name
Department of radiology and urology, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Rouvière, Pr
Phone
4 72 11 61 67
Ext
+33
Email
olivier.rouviere@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Sébastien Crouzet, Pr
Facility Name
Department of radiology and urology, Hôpital Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Favie Bratan, MD
Phone
4 78 61 88 00
Ext
+33
Email
fbratan@ch-stjoseph-stluc-lyon.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Arfi, MD
Facility Name
Department of Radiology and Urology, Hopital Européen Marseille
City
Marseille
ZIP/Postal Code
13003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc André, MD
First Name & Middle Initial & Last Name & Degree
Antoine Van Hove, MD
Facility Name
Department of Radiology and Urology, Institut Paoli-Calmettes Marseille
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Brunelle, MD
Phone
4 91 22 34 19
Ext
+33
Email
brunelles@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Jochen Walz, MD
Facility Name
Department of Urology, Clinique Beausoleil Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Poinas, Dr
Phone
4 67 459365
Ext
+33
Email
g.poinas@languedoc-mutualite.fr
Facility Name
Department of urology and Radiology
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Millet, Pr
Phone
6 78 88 71 74
Ext
+33
Email
i-millet@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Rodolphe Thuret, Pr
Facility Name
Department Urology, Clinique urologique Nantes Atlantis
City
Nantes
ZIP/Postal Code
44800
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Potiron, MD
Phone
2 28 03 04 44
Ext
+33
Email
ep@cliniqueuro.com
Facility Name
Department of radiology and urology, Hôpital la Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaele renardpenna, Pr
Phone
1 42 17 82 15
Ext
+33
Email
raphaele.renardpenna@aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre Mozer, Pr
Facility Name
Department of radiology, Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jean-michel correas, Pr
Phone
1 44 49 41 40
Ext
+33
Email
jean-michel.correas@aphp.fr
Facility Name
Department of urology and radiology, CHLS
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Moldovan, MD
Phone
4 72 11 12 31
Ext
+33
Email
paul-cezar.moldovan@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Alain Ruffion, Pr
Facility Name
Department of Urology, Quint Fonsegrives
City
Quint Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Ploussard, MD/PhD
Phone
5 32 02 72 02
Ext
+33
Email
gploussard@capio.fr
Facility Name
Department of urology, CHU de Saint-Étienne Hôpital Nord
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Mottet-Auselot, Pr
Phone
4 77 82 83 31
Ext
+33
Email
nicolas.mottet@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Remi Grange, Dr
Facility Name
Department of Radiology and Urology, Nouvel Hôpital Civil - CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Roy, Pr
Phone
3 69 55 07 31
Ext
+33
Email
catherine.roy@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Thibault Tricard, Pr
Facility Name
Department of Radiology adn Urology, Institut Universitaire du Cancer ,Toulouse
City
Toulouse
ZIP/Postal Code
231059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aziza richard, MD
Phone
5 31 15 60 60
Ext
+33
Email
aziza.richard@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
bernard malavaud, Pr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of the results of the trial, the CHANGE cohort will be made partially accessible to other investigators wishing to test a CAD system aimed at detecting/localizing prostate cancer on MR images while respecting patient information. Request for access to pseudonymized data will be reviewed by the Trial Steering Committee that will grant access or not. To gain access, requestors will be required to sign a data access agreement. Of note, investigators will have access only to the MR images and not to the histological findings. After analysis of the CHANGE MR images by their CAD system, the investigator will be requested to send the results to the Hospices Civils de Lyon. The comparison between the CAD findings and the targeted and systematic biopsy findings will be made by the Hospices Civils de Lyon that will then inform the investigator of the CAD diagnostic performance.
Citations:
PubMed Identifier
35140147
Citation
Rouviere O, Souchon R, Lartizien C, Mansuy A, Magaud L, Colom M, Dubreuil-Chambardel M, Debeer S, Jaouen T, Duran A, Rippert P, Riche B, Monini C, Vlaeminck-Guillem V, Haesebaert J, Rabilloud M, Crouzet S. Detection of ISUP >/=2 prostate cancers using multiparametric MRI: prospective multicentre assessment of the non-inferiority of an artificial intelligence system as compared to the PI-RADS V.2.1 score (CHANGE study). BMJ Open. 2022 Feb 9;12(2):e051274. doi: 10.1136/bmjopen-2021-051274.
Results Reference
derived

Learn more about this trial

Detection of ISUP≥2 Prostate Cancers Using Multiparametric MRI: Prospective Multicenter Comparison of the PI-RADS Score and an Artificial Intelligence System

We'll reach out to this number within 24 hrs