Thyroid CancerNCT07496684
Application and Evaluation of Vision-LSTM Modeling in Diagnostic Ultrasound Imaging of TI-RADS Category 4b Thyroid Nodules
An observational study of Thyroid Cancer, run by Ma Zhe at 1 site in China.
Trial summary
The aim of this study was to evaluate the performance of artificial intelligence (AI) technology in the diagnosis of thyroid nodules, specifically in the field of ultrasound image analysis. Read more about this study
- Who is it for?
- Ages 20 to 78 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- 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 20 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thyroid nodules who were seen at the First Affiliated Hospital of Shandong First Medical University from January 2022 to December 2024
Inclusion Criteria:(1) Patients with thyroid nodules visible on ultrasound who underwent biopsy and/or surgical resection. (2) Diagnosed as TI-RADS category 4b on the basis of preoperative ultrasound images by two sonographers with more than 5 years of experience in thyroid ultrasound diagnosis. (3) All nodules underwent puncture biopsy or surgery to obtain pathologic results.
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Exclusion Criteria:(1)The quality of the patient's ultrasound images was poor. (2) The patient has incomplete clinical and imaging data. (3) The patient has had thyroid surgery or other treatment.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application and Evaluation of Vision-LSTM Model in Diagnostic Ultrasound Imaging of TI-RADS Class 4b Thyroid Nodules
The aim of this study was to evaluate the performance of artificial intelligence (AI) technology in the diagnosis of thyroid nodules, specifically in the field of ultrasound image analysis. It focuses on the accuracy and clinical feasibility of the AI system based on the Vision-LSTM model in the diagnosis of TI-RADS category 4b thyroid nodules.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| maligant | patients with maligant thyroid masses who underwent biopsy and/or surgical resection. | |
| benign | patients with benign thyroid masses who underwent biopsy and/or surgical resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of diagnostic models
The study collected ultrasound imaging data from 401 cases of TI-RADS 4b thyroid nodules at our hospital and used this data to train and validate the Vision-LSTM model. The diagnostic results of the AI model were compared with those of junior and senior clinicians to evaluate its performance in terms of diagnostic accuracy and stability; model performance was quantified using metrics such as the area under the curve (AUC) and the precision-recall curve (PR curve).
Measured: Immediately evaluated after the diagnostic model was built
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ma Zhe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ma Zhe, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496684
- Sponsor's protocol ID
- 【2025】（S830）
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Evaluation of Vision-LSTM Model in Diagnostic Ultrasound Imaging of TI-RADS Class 4b Thyroid Nodules
- ClinicalTrials.gov ID
- NCT07496684
- Acronym / sponsor ID
- 【2025】（S830）
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Ma ZheUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Mar 2026 (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.
The aim of this study was to evaluate the performance of artificial intelligence (AI) technology in the diagnosis of thyroid nodules, specifically in the field of ultrasound image analysis. It focuses on the accuracy and clinical feasibility of the AI system based on the Vision-LSTM model in the diagnosis of TI-RADS category 4b thyroid nodules.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maligant | – | –patients with maligant thyroid masses who underwent biopsy and/or surgical resection. |
| benign | – | –patients with benign thyroid masses who underwent biopsy and/or surgical resection. |
Who may qualify
- Ages
- 20 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thyroid nodules who were seen at the First Affiliated Hospital of Shandong First Medical University from January 2022 to December 2024
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of diagnostic models
Time frame: Immediately evaluated after the diagnostic model was built
The study collected ultrasound imaging data from 401 cases of TI-RADS 4b thyroid nodules at our hospital and used this data to train and validate the Vision-LSTM model. The diagnostic results of the AI model were compared with those of junior and senior clinicians to evaluate its performance in terms of diagnostic accuracy and stability; model performance was quantified using metrics such as the area under the curve (AUC) and the precision-recall curve (PR curve).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thyroid Cancer, run by Ma Zhe 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?
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: finished, as of the sponsor's last update on 12 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of diagnostic models (time frame: Immediately evaluated after the diagnostic model was built). 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 12 Aug 2026.