An Algorithm Creation by Automated Segmentation by MRI for Bone and Muscles of Shoulder (SEGMENTATION)

March 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Elaboration of an Algorithm of Automated Segmentation by Magnetic Resonance Imaging for Bone and Muscles of Shoulder

The primary objective of the study is to develop an algorithm of automated segmentation of shoulder by MRI examinations.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a national monocentric study which will be conducted in Ambroise Paré hospital of APHP, in orthopaedics department (for enrollment) and radiological department (for CT-scan and MRI examinations) respectively.

Manual segmentations of 5 muscles and 2 bones of shoulder by MRI with automated segmentation of shoulders corresponding to CT-scan imagings.

3D imagings of each shoulder by manual segmentations from MRI and automated segmentation from computed tomography will provide to build a network.

The perspective of the elaborated algorithm should lead to an automated 3D-reconstruction of patients' shoulder as a routine care in surgery.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Orthopaedics, Ambroise Paré hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteer > 18 years, presenting any symptom nor history of shoulder pathology;
  • Affiliated to social security scheme.

Exclusion Criteria:

  • Symptoms or history of shoulder pathologies;
  • Claustrophobia;
  • Pregnant woman;
  • Patient covered by AME system;
  • Contre-indication to perform MRI examination (implant, less 6-months stent implantation, recent surgery, renal insufficiency, pace maker implantation, cardiac defibrillator, cardiovascular catheter, neurostimulation, implantable electronic pompe for automatic injection of medications).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
All participants are healthy volunteers
Procedure: CT-Scan and MRI
CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm developement
Time Frame: through study completion, an average of 8 month
The developement for automatic segmentation algorithm: uses method with a convolutional neural networks (convolutional neural network - CNN).
through study completion, an average of 8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-David Werthel, MD, Orthopaedics, Ambroise Paré hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Actual)

April 28, 2024

Study Completion (Actual)

April 28, 2024

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APHP220324
  • 2022-A00301-42 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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