- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299997
Evaluation of the PI-RADS v2.1 Score Using Multiple Readers (MULTI)
Accuracy of the PI-RADS v2.1 Score for Characterizing ISUP ≥2 Prostate Cancers on Multiparametric MRI: a Multiple Reader Study
The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.
The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 171 prostate MRIs using 21 readers of varying experience.
Twenty-one readers (14 seniors and 7 juniors) from 9 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.
Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69008
- Hôpital Edouard Herriot
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Prostate mpMRI and biopsy performed at our institution
- Performed between September 2015 and July 2016
- No history of prostate cancer at the time of the mpMRI
Exclusion Criteria:
- Patients who already had treatment for prostate cancer
- Patients under Active Surveillance
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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171 mpMRIs corresponding to consecutive patients who underwent
The mpMRIs were performed on a 1.5T GE MR unit or on a 3T GE or Philips MR units.
All mpMRIs included T2-weighted imaging, diffusion-weighted imaging (maximal b value: 2000 s/mm²) and dynamic contrast-enhanced imaging.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion level.
Time Frame: June 2020.
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Analysis at the lesion level will be favored to get an evaluation of the influence of experience of readers scoring the exact same set of lesions.
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June 2020.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC of the PI-RADS v2.1 score for predicting ISUP ≥2 cancer at biopsy, at the lesionlobe and patient levels
Time Frame: June 2020
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June 2020
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Inter-reader concordance of the PI-RADS v2.1 score, at lesion, lobe and patient levels
Time Frame: June 2020
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June 2020
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AUC of the PI-RADS v2 score for predicting ISUP ≥2 cancer at subsequent biopsy at the lesion, lobe and patient levels
Time Frame: June 2020
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June 2020
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Inter-reader concordance of the PI-RADS v2 score at lesion, lobe and patient levels
Time Frame: June 2020
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June 2020
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AUC of the Likert score for predicting ISUP ≥2 cancer at biopsy at the lesion, lobe and patient levels
Time Frame: June 2020
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June 2020
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Inter-reader concordance of the Likert score at lesion, lobe and patient levels
Time Frame: June 2020
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June 2020
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Analysis of the diagnostic value of the PI-RADS v2.1 components
Time Frame: June 2020
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The PI-RADS v2.1 score is made by several components who have different diagnostic weights. The added value of the following components will be assessed:
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June 2020
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Added value of the Likert score
Time Frame: June 2020
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- This part will be only exploratory and narrative.
It is aimed at evaluating, at least for the most experienced readers, if there are circumstances in which the Likert score (i.e.
"gut feeling") is more predictive of ISUP ≥2 cancers than the PI-RADS v2.1 score.
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June 2020
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Description of patients with negative initial biopsy and who were diagnosed with ISUP ≥2 cancer after 3 years of follow-up
Time Frame: June 2020
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Because targeted and systematic biopsy may miss cancer foci, follow-up data will be retrieved from the patients' files.
Patients with no follow-up data within the last year will be reached by phone to update their follow-up.The patients with initial biopsy showing no cancer or ISUP 1 cancer and who were subsequently diagnosed with ISUP ≥2 cancers during the 3-year follow-up will be reported and described.
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June 2020
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Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- MULTI_2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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