An Algorithm Creation by Automated Segmentation by MRI fo... | NCT05376813

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

NCT05376813

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Mar 19, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Reverse Shoulder Prosthesis

Interventions

CT-Scan and MRI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-A00301-42	Registry Identifier	IDRCB

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

NO ENROULEMENT

Expanded Access Info

Start Date

Aug 31, 2023Actual

Primary Completion Date

Apr 28, 2024Actual

Completion Date

Apr 28, 2024Actual

First Submitted Date

May 9, 2022

First Submission Date that Met QC Criteria

May 16, 2022

First Posted Date

May 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental arm	Experimental	All participants are healthy volunteers	Procedure: CT-Scan and MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-Scan and MRI	Procedure	CT-Scan and MRI examination for shoulder will be performed on healthy volunteers.	Experimental arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Algorithm developement	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-David Werthel, MD	Orthopaedics, Ambroise Paré hospital, APHP	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided