- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04191980
Deep Learning for Prostate Segmentation (GOPI-Segm)
Multi-zone Computer-aided Prostate Segmentation on MR Images Using a Deep Learning-based Approach
Because the diagnostic criteria for prostate cancer are different in the peripheral and the transition zone, prostate segmentation is needed for any computer-aided diagnosis system aimed at characterizing prostate lesions on magnetic resonance (MR) images. Manual segmentation is time consuming and may differ between radiologists with different expertise. We developed and trained a convolutional neural network algorithm for segmenting the whole prostate, the transition zone and the anterior fibromuscular stroma on T2-weighted images of 787 MRIs from an existing prospective radiological pathological correlation database containing prostate MRI of patients treated by prostatectomy between 2008 and 2014 (CLARA-P database).
The purpose of this study is to validate this algorithm on an independent cohort of patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Lyon, France, 69008
- Recruiting
- Hôpital Edouard Herriot
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Contact:
- Olivier ROUVIERE, Pr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Prostate MRI contained in the PACS of the Hospices Civils de Lyon
- Performed in 2016-2019
Exclusion Criteria:
- MRIs from patients who already had treatment for prostate cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with a MRI on a 3 Tesla (T) unit
The total validation cohort is composed of axial T2-weighted images of the prostate obtained from 31 prostate MRIs on a 3T unit randomly chosen among the prostate MRIs performed at the Hospices Civils de Lyon in 20162015-2019
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The algorithm is used to perform a multizone segmentation of the prostate including delineation of : the whole prostate contours, the transition zone contours, the anterior fibromuscular stroma. The contours is independently corrected by 2 radiologists. The corrected contours of the different zones will be stored and for each zone 6 different metrics will be used to evaluate the difference between the initial and corrected contours:
|
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Patients with a MRI on a 1.5 Tesla unit
The total validation cohort is composed of axial T2-weighted images of the prostate obtained from 31 prostate MRIs on a 1.5T unit randomly chosen among the prostate MRIs performed at the Hospices Civils de Lyon in 20162015-2019
|
The algorithm is used to perform a multizone segmentation of the prostate including delineation of : the whole prostate contours, the transition zone contours, the anterior fibromuscular stroma. The contours is independently corrected by 2 radiologists. The corrected contours of the different zones will be stored and for each zone 6 different metrics will be used to evaluate the difference between the initial and corrected contours:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Mesh Distance (Mean) between the contours of the whole prostate made by the algorithm and the two radiologists
Time Frame: Month 11
|
The Mean Mesh Distance corresponds to the Average Boundary Distance (ABD) for each point of the reference segmentation. The distance to the closest point of the compared segmentation is first computed. Then the average of all these distances is computed and gives the ABD. The Mean Mesh Distance between the contours of the whole prostate made by the algorithm and each radiologist will be used as primary outcome measure. |
Month 11
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- GOPI-Segmentation_2019
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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