NCT06845462

Brief Summary

To establish an artificial intelligence model for automated diagnosis of sarcopenia based on CT imaging

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,080

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • To automatedly and precisely quantify three-dimensional muscle volume and fat volume.

    To achieve an automated and precise quantification of three-dimensional muscle volume and fat volume at the L3 vertebral region by deep learning.

    2020-2023

  • To establish an artificial intelligence model for diagnosis of sarcopenia.

    The validation of artificial intelligence models can assist in the diagnosis of sarcopenia.

    2020-2023

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

960 inpatients in the geriatric department of Renji Hospital, 20 patients from Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, 20 patients from The First Affiliated Hospital of Zhejiang Medical University, 50 patients from The First Affiliated Hospital of Wenzhou Medical University, and 30 patients from Huangshan People's Hospital.

You may qualify if:

  • The population undergoing BIA and abdominal CT examinations;
  • Can cooperate to complete human body composition analysis, grip strength measurement, 6m walking time measurement, and questionnaire survey.

You may not qualify if:

  • Age\<18 years old;
  • Existence of abdominal wall edema;
  • History of spinal surgery or vertebral fractures, or vertebral tumor lesions;
  • History of neuromuscular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee

Shanghai, Shanghai Municipality, 2000127, China

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrative Director of Geriatrics Department

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

September 5, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations