SarcopeniaNCT06199856
Assessment System for Sarcopenia Based on Ultrasonographic Data
An observational study of Sarcopenia and Ultrasound, run by West China Hospital at 1 site in China.
Trial summary
1. To develop an artificial intelligence assisted diagnostic model for sarcopenia based on ultrasound images; 2. To develop artificial intelligence classification and regression models for auxiliary diagnosis of sarcopenia, patient strength estimation, and other functions based on ultrasound image data. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Ultrasound
- What is being tested?
- ultrasound scan
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The older adults with risk of sarcopenia
Who may be able to join
- > 50 years of age
- Patients with suspected sarcopenia, for example, who needed assistance with walking, rising from a chair, or climbing stairs; recently had a history of falls walking; recent unintentional weight loss
Who cannot join
- Amputated arm or leg
- Severe oedema (oedema higher than knee level)
- Implantable pacemaker
- Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinyi Tang
Chengdu, Sichuan
Xinyi Tang, Dr., +8615680819215
About this study
Official title: An Artificial Intelligence Assessment System for Risk Grading of Sarcopenia Based on Ultrasonographic Multidimensional Data
- To develop an artificial intelligence assisted diagnostic model for sarcopenia based on ultrasound images;
- To develop artificial intelligence classification and regression models for auxiliary diagnosis of sarcopenia, patient strength estimation, and other functions based on ultrasound image data.
Read the detailed description
Sarcopenia is a syndrome of age-related muscle mass loss and muscle function decrease, which can be comorbid with a variety of diseases and interacts extensively with various disease states to influence disease prognosis. Diseases such as cancer, diabetes, chronic kidney disease, and rheumatoid arthritis can accelerate the process of muscle loss by affecting myogenic cell regeneration, interfering with protein synthesis, increasing protein consumption, and enhancing protein degradation by the ubiquitination pathway, and the decline in motor function will, in turn, further worsen the prognosis of the disease. Despite some regional differences, the prevalence of sarcopenia has been found to exceed 10%. Early identification of the potential risk of sarcopenia and early intervention in the early stages of muscle mass and function impairment is one of the most important steps to improve the quality of life of older adults.
Currently, the diagnosis of sarcopenia relies on three features: loss of muscle mass, loss of muscle strength, and loss of physical performance. At present, physicians usually use bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) to determine skeletal muscle mass index SMI to measure muscle mass, grip strength test to measure muscle strength, gait speed or tools such as SPPB scores to assess physical performance. A diagnosis of sarcopenia can be made when a subject experiences a decrease in SMI combined with a decrease in grip strength or a decrease in gait speed.
In the field of medical imaging, researchers have been working to explore and validate appropriate imaging tools and markers to diagnose and evaluate sarcopenia. The common methods for deep mining of medical imaging include radiomics and machine learning, usually by analyzing the texture features of muscles at specific sites to quantify muscle function or segmenting skeletal muscles accurately in two dimensions or three dimensions to quantify muscle mass. Compared to computed tomography (CT) or magnetic resonance imaging (MRI), ultrasound is a more accessible and less costly medical imaging technique, especially in low- and middle-income regions. Ultrasound can be used to conveniently scan local muscles and obtain muscle characteristics such as muscle thickness, cross-sectional area, and pennation angle. Our previous studies have demonstrated that SMI in older adults can be accurately estimated by using muscle thickness at four sites together with basic information such as age and body mass index (BMI), and have found in cross-regional validation that the stability of estimates can be maintained across communities with very different ethnic proportions. However, several existing large studies on ultrasound in sarcopenia are currently focusing only on muscle morphological measurements, ignoring the large amount of hidden ultrasound image information. At the same time, the flexibility of the scanning process has led to greater resistance from radiomics or deep learning tools to use the images for artificial intelligence classification than CT or MRI.
Fronted with such a dilemma, we attempted to establish an intelligent risk grading system for sarcopenia, based on multidimensional data including basic information such as age and BMI, ultrasound measurements, and original image content, to complete the risk grading of sarcopenia in older adults in a one-stop manner, so as to realize the rapid screening and classification of potential sarcopenia populations for further clinical management.
- Conditions
- Sarcopenia, Ultrasound
- Being tested
- ultrasound scan
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound scanDiagnostic test
ultrasound scan
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized older adults at risk of sarcopenia | Not described Receives: Diagnostic Test: ultrasound scan | |
| Community-dwelling older adults at risk of sarcopenia | Not described Receives: Diagnostic Test: ultrasound scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: Within 2 years after the initial ultrasound examination
Diagnosed sarcopenia
Skeletal muscle mass index (SMI)<7 (men) /5.7 (women)kg/m2 (measured by BIA) and gait speed<1m/s or grip strength<28kg (men)/18kg (women)
Measured: Within 2 years after the initial ultrasound examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Oct 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyi Tang, West China Hospital
- Investigators
- Xinyi Tang, Dr., Principal investigator, Department of Medical Ultrasound, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199856
- Sponsor's protocol ID
- XTang-0001
- Status last verified
- Mar 2025
- First submitted
- 28 Dec 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By submitting an application to the project leader via email and obtaining approval from relevant hospital departments
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial Intelligence Assessment System for Risk Grading of Sarcopenia Based on Ultrasonographic Multidimensional Data
- ClinicalTrials.gov ID
- NCT06199856
- Acronym / sponsor ID
- XTang-0001
- Conditions
- Sarcopenia, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To develop an artificial intelligence assisted diagnostic model for sarcopenia based on ultrasound images;
- To develop artificial intelligence classification and regression models for auxiliary diagnosis of sarcopenia, patient strength estimation, and other functions based on ultrasound image data.
Detailed description
Sarcopenia is a syndrome of age-related muscle mass loss and muscle function decrease, which can be comorbid with a variety of diseases and interacts extensively with various disease states to influence disease prognosis. Diseases such as cancer, diabetes, chronic kidney disease, and rheumatoid arthritis can accelerate the process of muscle loss by affecting myogenic cell regeneration, interfering with protein synthesis, increasing protein consumption, and enhancing protein degradation by the ubiquitination pathway, and the decline in motor function will, in turn, further worsen the prognosis of the disease. Despite some regional differences, the prevalence of sarcopenia has been found to exceed 10%. Early identification of the potential risk of sarcopenia and early intervention in the early stages of muscle mass and function impairment is one of the most important steps to improve the quality of life of older adults.
Currently, the diagnosis of sarcopenia relies on three features: loss of muscle mass, loss of muscle strength, and loss of physical performance. At present, physicians usually use bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA) to determine skeletal muscle mass index SMI to measure muscle mass, grip strength test to measure muscle strength, gait speed or tools such as SPPB scores to assess physical performance. A diagnosis of sarcopenia can be made when a subject experiences a decrease in SMI combined with a decrease in grip strength or a decrease in gait speed.
In the field of medical imaging, researchers have been working to explore and validate appropriate imaging tools and markers to diagnose and evaluate sarcopenia. The common methods for deep mining of medical imaging include radiomics and machine learning, usually by analyzing the texture features of muscles at specific sites to quantify muscle function or segmenting skeletal muscles accurately in two dimensions or three dimensions to quantify muscle mass. Compared to computed tomography (CT) or magnetic resonance imaging (MRI), ultrasound is a more accessible and less costly medical imaging technique, especially in low- and middle-income regions. Ultrasound can be used to conveniently scan local muscles and obtain muscle characteristics such as muscle thickness, cross-sectional area, and pennation angle. Our previous studies have demonstrated that SMI in older adults can be accurately estimated by using muscle thickness at four sites together with basic information such as age and body mass index (BMI), and have found in cross-regional validation that the stability of estimates can be maintained across communities with very different ethnic proportions. However, several existing large studies on ultrasound in sarcopenia are currently focusing only on muscle morphological measurements, ignoring the large amount of hidden ultrasound image information. At the same time, the flexibility of the scanning process has led to greater resistance from radiomics or deep learning tools to use the images for artificial intelligence classification than CT or MRI.
Fronted with such a dilemma, we attempted to establish an intelligent risk grading system for sarcopenia, based on multidimensional data including basic information such as age and BMI, ultrasound measurements, and original image content, to complete the risk grading of sarcopenia in older adults in a one-stop manner, so as to realize the rapid screening and classification of potential sarcopenia populations for further clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized older adults at risk of sarcopenia | – | Diagnostic Test: ultrasound scan |
| Community-dwelling older adults at risk of sarcopenia | – | Diagnostic Test: ultrasound scan |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The older adults with risk of sarcopenia
Key inclusion criteria (2 listed)
- > 50 years of age
- Patients with suspected sarcopenia, for example, who needed assistance with walking, rising from a chair, or climbing stairs; recently had a history of falls walking; recent unintentional weight loss
Key exclusion criteria (4 listed)
- Amputated arm or leg
- Severe oedema (oedema higher than knee level)
- Implantable pacemaker
- Impaired consciousness, poor general health, or other reasons that would prevent the individual from completing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound scanultrasound scan | Diagnostic test | Community-dwelling older adults at risk of sarcopenia, Hospitalized older adults at risk of sarcopenia |
Primary outcome
Death
Time frame: Within 2 years after the initial ultrasound examination
Diagnosed sarcopenia
Time frame: Within 2 years after the initial ultrasound examination
Skeletal muscle mass index (SMI)<7 (men) /5.7 (women)kg/m2 (measured by BIA) and gait speed<1m/s or grip strength<28kg (men)/18kg (women)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided. By submitting an application to the project leader via email and obtaining approval from relevant hospital departments
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyi Tang, Dr. principal investigator
Department of Medical Ultrasound, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Ultrasound, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi Tang, Dr. (+8615680819215, tangxinyi1996@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Within 2 years after the initial ultrasound examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.