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

NCT ID: NCT05376813

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-04-28

Brief Summary

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

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.

Conditions

Reverse Shoulder Prosthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental arm

All participants are healthy volunteers

Group Type: EXPERIMENTAL

CT-Scan and MRI

Intervention Type: PROCEDURE

CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.

Interventions

CT-Scan and MRI

CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-David Werthel, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedics, Ambroise Paré hospital, APHP

Other Identifiers

2022-A00301-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP220324

Identifier Type: -

Identifier Source: org_study_id