Endocrine DiseasesNCT05137301
Performance of the Diagnostic Value of Bone Age Assessment Software Based on Deep Learning in Chinese Children
An observational study of Endocrine Diseases, run by Tongji Hospital at 1 site in China.
Trial summary
High accuracy and precision bone age assessment is very important for the diagnosis and treatment monitoring of various pediatric diseases. The commonly used bone age assessment methods include GP atlas, TW3 score and Zhonghua 05. GP method is to compare wrist X-ray films with atlas reference X-ray films. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine Diseases
- What is being tested?
- X-ray bone age instrument
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2022to 31 Dec 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged 1-18 who need bone age assessment
Who may be able to join
- Children aged 1 to 18 years.
- Clinical diagnosis of requiring bone age examination.
Who cannot join
- There are obstructions or implants in the wrist bone, such as metal.
- Poor resolution, which affects the observation of bone characteristics.
- Poor shooting position of the wrist due to various reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei
xiaoping luo, director, 13387522645, xpluo@tjh.tjmu.edu.cn
xiaoping luo, director
About this study
High accuracy and precision bone age assessment is very important for the diagnosis and treatment monitoring of various pediatric diseases. The commonly used bone age assessment methods include GP atlas, TW3 score and Zhonghua 05. GP method is to compare wrist X-ray films with atlas reference X-ray films. Its main disadvantages are strong subjectivity and long atlas standard interval. Different from GP method, TW3 method is to grade and score each bone, add each epiphyseal score to calculate the total score of bone maturity, and obtain the corresponding final bone age value. Although TW3 scoring method is relatively accurate, it is complex and time-consuming, and there is great variability among evaluators. In order to evaluate bone age more efficiently and accurately, a method based on computer image automatic recognition technology can help to overcome these problems.
In this study, 1000 children aged 1-18 in 5 hospitals are selected as the research objects. After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.
The purpose of this study is to use the most advanced artificial intelligence deep learning bone age evaluation software to explore the value of bone age instrument to improve the accuracy and diagnostic efficiency of bone age evaluation by pediatricians.
Read the detailed description
- Study subjects: Radiographs of the left wrist of 1000 children aged 1-18 years who underwent bone age measurement at 5 hospitals were selected
- Research methods:
2.1 general information: name, gender, actual age, height, weight, BMI, race, disease type 2.2 main instrument: artificial intelligence X-ray bone age instrument 2.3 scanning scheme: Left posterior and anterior radiographs 2.4 bone age evaluation method and group 2.4.1 the standard group：Tw3-RUS and TW3-CARPAL were used to evaluate the left hand bone age tablets by the 5 pediatric doctors designated in the TW3 system training. There was no time limit for reading the tablets. The mean value of the evaluation results of the 5 doctors was taken as the final reference standard.
2.4.2 Grouping of bone age assessment ① artificial group (5 assessors assess bone age separately) ② AI Group③ artificial + AI Group (artificial Group assesses bone age with the assistance of AI intelligent software assessment) After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.
- Conditions
- Endocrine Diseases
- Being tested
- X-ray bone age instrument
- Keywords
- bone age; TW3; AI
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray bone age instrumentDevice
Bone age films were taken by X-ray bone age instrument
What is being measured
The primary outcome is the main question the study is designed to answer.
bone age
The mean absolute error (MAE) and root mean square error (RSME) between the evaluation bone age results of different groups
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start21 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DiseasesStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Xiaoping Luo, Tongji Hospital
- Investigators
- xiumin wang, director, Principal investigator, Shanghai Children's Medical Centerxinran cheng, director, Principal investigator, Chendu Women's and children's central hospitalxiaobo chen, director, Principal investigator, Children's Hospital of The Capital Institute of PediatricsZE SU, director, Principal investigator, Shenzhen Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137301
- Sponsor's protocol ID
- GenSci-GD-21001
- Status last verified
- Apr 2023
- First submitted
- 11 Nov 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Diagnostic Value of Bone Age Assessment Software Based on Deep Learning in Chinese Children
- ClinicalTrials.gov ID
- NCT05137301
- Acronym / sponsor ID
- GenSci-GD-21001
- Conditions
- Endocrine Diseases
- Keywords
- bone age; TW3; AI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Nov 2021 (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.
High accuracy and precision bone age assessment is very important for the diagnosis and treatment monitoring of various pediatric diseases. The commonly used bone age assessment methods include GP atlas, TW3 score and Zhonghua 05. GP method is to compare wrist X-ray films with atlas reference X-ray films. Its main disadvantages are strong subjectivity and long atlas standard interval. Different from GP method, TW3 method is to grade and score each bone, add each epiphyseal score to calculate the total score of bone maturity, and obtain the corresponding final bone age value. Although TW3 scoring method is relatively accurate, it is complex and time-consuming, and there is great variability among evaluators. In order to evaluate bone age more efficiently and accurately, a method based on computer image automatic recognition technology can help to overcome these problems.
In this study, 1000 children aged 1-18 in 5 hospitals are selected as the research objects. After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.
The purpose of this study is to use the most advanced artificial intelligence deep learning bone age evaluation software to explore the value of bone age instrument to improve the accuracy and diagnostic efficiency of bone age evaluation by pediatricians.
Detailed description
- Study subjects: Radiographs of the left wrist of 1000 children aged 1-18 years who underwent bone age measurement at 5 hospitals were selected
- Research methods:
2.1 general information: name, gender, actual age, height, weight, BMI, race, disease type 2.2 main instrument: artificial intelligence X-ray bone age instrument 2.3 scanning scheme: Left posterior and anterior radiographs 2.4 bone age evaluation method and group 2.4.1 the standard group：Tw3-RUS and TW3-CARPAL were used to evaluate the left hand bone age tablets by the 5 pediatric doctors designated in the TW3 system training. There was no time limit for reading the tablets. The mean value of the evaluation results of the 5 doctors was taken as the final reference standard.
2.4.2 Grouping of bone age assessment ① artificial group (5 assessors assess bone age separately) ② AI Group③ artificial + AI Group (artificial Group assesses bone age with the assistance of AI intelligent software assessment) After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged 1-18 who need bone age assessment
Key inclusion criteria (2 listed)
- Children aged 1 to 18 years.
- Clinical diagnosis of requiring bone age examination.
Key exclusion criteria (3 listed)
- There are obstructions or implants in the wrist bone, such as metal.
- Poor resolution, which affects the observation of bone characteristics.
- Poor shooting position of the wrist due to various reasons.
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 |
|---|---|---|
| X-ray bone age instrumentBone age films were taken by X-ray bone age instrument | Device | – |
Primary outcome
bone age
Time frame: one month
The mean absolute error (MAE) and root mean square error (RSME) between the evaluation bone age results of different groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
xiumin wang, director principal investigator
Shanghai Children's Medical Center
xinran cheng, director principal investigator
Chendu Women's and children's central hospital
xiaobo chen, director principal investigator
Children's Hospital of The Capital Institute of Pediatrics
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 Endocrine Diseases, run by Tongji 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 3 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Luo, director (13387522645, xpluo@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone age (time frame: one month). 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 20 Apr 2023.