NCT04191980

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

December 6, 2019

Last Update Submit

December 6, 2019

Conditions

Keywords

prostate segmentationMR images

Outcome Measures

Primary Outcomes (1)

  • Mean Mesh Distance (Mean) between the contours of the whole prostate made by the algorithm and the two radiologists

    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

Study Arms (2)

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

Other: Comparison of prostate multi-zone segmentation obtained with an automatic deep learning-based algorithm and two expert radiologists

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

Other: Comparison of prostate multi-zone segmentation obtained with an automatic deep learning-based algorithm and two expert radiologists

Interventions

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: * Mean Mesh Distance: 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 * General Hausdorff distance (HD) * 95% percentile (P) of the HD and the 95th (P) of the asymmetric HD distribution * 95% HD modified (HD95\_1): different approach by first computing the 95th (P) of the asymmetric HD then taking the maximum * Dice coefficient * Difference in volumes

Patients with a MRI on a 1.5 Tesla unitPatients with a MRI on a 3 Tesla (T) unit

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random selection in the Picture Archiving and Communication System (PACS) of the Hospices Civils de Lyon among examinations performed between 2016 and 2019

You may qualify if:

  • Prostate MRI contained in the PACS of the Hospices Civils de Lyon
  • Performed in 2016-2019

You may not qualify if:

  • MRIs from patients who already had treatment for prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Olivier ROUVIERE, Pr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 10, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations