Thyroid AbnormalitiesNCT07296575
Ultrasound Large-scale Model in Thyroid Field: A Multi-center Study on Medical-Engineering Integration
An observational study of Thyroid Abnormalities and Thyroid, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
The goal of this observational study is to evaluate the diagnostic accuracy and clinical workflow integration of an ultrasound intelligent agent (UIA) for thyroid disease management in a real-world multicenter setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thyroid Abnormalities, Thyroid, Thyroid Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with clinically suspected thyroid abnormalities who have been prescribed a thyroid ultrasound examination
Who may be able to join
- Ages 18-80, clinically suspected thyroid disease (e.g., enlargement, nodules, pain) requiring ultrasound examination;
- Diffuse lesions must demonstrate both ultrasound characteristics and laboratory evidence;
- Dynamic video must fully cover the maximum diameter of the nodule without significant probe movement;
- Voluntary signed informed consent.
Who cannot join
- Poor image quality (severe gas interference, artifacts obscuring structural visualization);
- Inability to cooperate with examination (consciousness impairment, extreme non-compliance);
- Prior participation in other thyroid ultrasound-related clinical trials; postoperative thyroid recurrence;
- Thyroid malformation/ectopia affecting visualization.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
Official title: A Multicenter Study on Multimodal Diagnosis and Process Optimization of Thyroid Diseases Based on Ultrasonic Intelligent Agents
The goal of this observational study is to evaluate the diagnostic accuracy and clinical workflow integration of an ultrasound intelligent agent (UIA) for thyroid disease management in a real-world multicenter setting. The primary research question is:
Can the UIA improve diagnostic consistency and efficiency for thyroid nodules (TI-RADS 1-5), Hashimoto's thyroiditis, and cervical lymph node metastasis compared to traditional ultrasound interpretation? Participants will include adults (18-80 years) undergoing thyroid ultrasound at 16 participating hospitals across China. Key inclusion criteria cover patients with suspected thyroid disorders requiring imaging, while exclusion criteria address poor image quality or concurrent clinical trials. Over 2,000 cases (50% thyroid nodules, 30% diffuse lesions, 12.5% non-nodular abnormalities, 7.5% special populations) will be prospectively enrolled. Data collection integrates static/dynamic ultrasound images, laboratory results, and AI-generated reports. Primary endpoints include model performance metrics (AUC, sensitivity/specificity, TI-RADS Kappa ≥0.8), workflow efficiency (report generation time ≤5 minutes), and pediatric/pregnancy-specific reference standards. Secondary analyses will assess inter-rater reliability (Cohen's Kappa) and longitudinal outcomes via 6-12-month follow-up. This study aims to establish evidence-based guidelines for AI-augmented thyroid diagnosis, particularly in underserved regions, while addressing gaps in current AI validation frameworks related to multi-modality data fusion and special population adaptability.
- Conditions
- Thyroid Abnormalities, Thyroid, Thyroid Cancer
- Being tested
- No intervention
- Keywords
- thyroid, Artificial Intelligence, Ultrasound
- Medical subject headings
- Thyroid Diseases, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
no Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Performance of Large Models in Ultrasound Thyroid Applications for Thyroid Diseases
Diagnosing thyroid diseases using a large model in the field of ultrasound thyroid imaging, with histopathological examination results of thyroid lesions as the gold standard, to evaluate the model's sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) for diagnosing thyroid diseases.
Measured: Within 12 months of enrollment for each patient at the time of study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid AbnormalitiesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Gannan Medical University, Ganzhou City People's Hospital, Tumor Hospital of Jiangxi Province, Chudong Medical Group Hospital (Yugan County), Zhengzhou Third People's Hospital, Xuzhou Traditional Chinese Medicine Hospital, Yifu Hospital Affiliated to Nanjing Medical University, Fuyang people's hospital, General Hospital of Ningxia Medical University, Jinan Central Hospital, Harbin First Specialized Hospital, Sun Yat-sen University, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yancheng First People's Hospital, Yangling Demonstration Zone Hospital of Shaanxi Province, Beijing Friendship Hospital, Fengfeng Mineral Bureau General Hospital of Hebei Province, Hunan Provincial Tumor Hospital, First Affiliated Hospital of Pingdingshan University, 908th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force, Bai Cheng Central Hospital, PLA No. 901 Hospital of the Joint Support Force, The Affiliated Hospital of Jinggangshan University, Ji'an Third People's Hospital
- Responsible party
- Principal investigator, Chunquan Zhang, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296575
- Sponsor's protocol ID
- SecondNanchangU2025
- Other IDs
- IIT-O-2025-343
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tessler FN, Middleton WD, Grant EG, Hoang JK, Berland LL, Teefey SA, Cronan JJ, Beland MD, Desser TS, Frates MC, Hammers LW, Hamper UM, Langer JE, Reading CC, Scoutt LM, Stavros AT. ACR Thyroid Imaging, Reporting and Data System (TI-RADS): White Paper of the ACR TI-RADS Committee. J Am Coll Radiol. 2017 May;14(5):587-595. doi: 10.1016/j.jacr.2017.01.046. Epub 2017 Apr 2.
PubMed 28372962de Carlos J, Garcia J, Basterra FJ, Pineda JJ, Dolores Ollero M, Toni M, Munarriz P, Anda E. Interobserver variability in thyroid ultrasound. Endocrine. 2024 Aug;85(2):730-736. doi: 10.1007/s12020-024-03731-5. Epub 2024 Feb 19.
PubMed 38372907Patel J, Klopper J, Cottrill EE. Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities. Front Endocrinol (Lausanne). 2023 Feb 24;14:1101410. doi: 10.3389/fendo.2023.1101410. eCollection 2023.
PubMed 36909304
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on Multimodal Diagnosis and Process Optimization of Thyroid Diseases Based on Ultrasonic Intelligent Agents
- ClinicalTrials.gov ID
- NCT07296575
- Acronym / sponsor ID
- SecondNanchangU2025
- Conditions
- Thyroid Abnormalities, Thyroid, Thyroid Cancer
- Keywords
- thyroid, Artificial Intelligence, Ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Gannan Medical University, Ganzhou City People's Hospital, Tumor Hospital of Jiangxi Province, Chudong Medical Group Hospital (Yugan County), Zhengzhou Third People's Hospital, Xuzhou Traditional Chinese Medicine Hospital, Yifu Hospital Affiliated to Nanjing Medical University, Fuyang people's hospital, General Hospital of Ningxia Medical University, Jinan Central Hospital, Harbin First Specialized Hospital, Sun Yat-sen University, Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Yancheng First People's Hospital, Yangling Demonstration Zone Hospital of Shaanxi Province, Beijing Friendship Hospital, Fengfeng Mineral Bureau General Hospital of Hebei Province, Hunan Provincial Tumor Hospital, First Affiliated Hospital of Pingdingshan University, 908th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force, Bai Cheng Central Hospital, PLA No. 901 Hospital of the Joint Support Force, The Affiliated Hospital of Jinggangshan University, Ji'an Third People's Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (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 goal of this observational study is to evaluate the diagnostic accuracy and clinical workflow integration of an ultrasound intelligent agent (UIA) for thyroid disease management in a real-world multicenter setting. The primary research question is:
Can the UIA improve diagnostic consistency and efficiency for thyroid nodules (TI-RADS 1-5), Hashimoto's thyroiditis, and cervical lymph node metastasis compared to traditional ultrasound interpretation? Participants will include adults (18-80 years) undergoing thyroid ultrasound at 16 participating hospitals across China. Key inclusion criteria cover patients with suspected thyroid disorders requiring imaging, while exclusion criteria address poor image quality or concurrent clinical trials. Over 2,000 cases (50% thyroid nodules, 30% diffuse lesions, 12.5% non-nodular abnormalities, 7.5% special populations) will be prospectively enrolled. Data collection integrates static/dynamic ultrasound images, laboratory results, and AI-generated reports. Primary endpoints include model performance metrics (AUC, sensitivity/specificity, TI-RADS Kappa ≥0.8), workflow efficiency (report generation time ≤5 minutes), and pediatric/pregnancy-specific reference standards. Secondary analyses will assess inter-rater reliability (Cohen's Kappa) and longitudinal outcomes via 6-12-month follow-up. This study aims to establish evidence-based guidelines for AI-augmented thyroid diagnosis, particularly in underserved regions, while addressing gaps in current AI validation frameworks related to multi-modality data fusion and special population adaptability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinically suspected thyroid abnormalities who have been prescribed a thyroid ultrasound examination
Key inclusion criteria (4 listed)
- Ages 18-80, clinically suspected thyroid disease (e.g., enlargement, nodules, pain) requiring ultrasound examination;
- Diffuse lesions must demonstrate both ultrasound characteristics and laboratory evidence;
- Dynamic video must fully cover the maximum diameter of the nodule without significant probe movement;
- Voluntary signed informed consent.
Key exclusion criteria (4 listed)
- Poor image quality (severe gas interference, artifacts obscuring structural visualization);
- Inability to cooperate with examination (consciousness impairment, extreme non-compliance);
- Prior participation in other thyroid ultrasound-related clinical trials; postoperative thyroid recurrence;
- Thyroid malformation/ectopia affecting visualization.
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 |
|---|---|---|
| No interventionno Intervention | Diagnostic test | – |
Primary outcome
Predictive Performance of Large Models in Ultrasound Thyroid Applications for Thyroid Diseases
Time frame: Within 12 months of enrollment for each patient at the time of study completion.
Diagnosing thyroid diseases using a large model in the field of ultrasound thyroid imaging, with histopathological examination results of thyroid lesions as the gold standard, to evaluate the model's sensitivity, specificity, accuracy, and area under the receiver operating characteristic curve (AUC) for diagnosing thyroid diseases.
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 22 Dec 2025.
- Results publication: PubMed 28372962Tessler FN, Middleton WD, Grant EG, Hoang JK, Berland LL, Teefey SA, Cronan JJ, Beland MD, Desser TS, Frates MC, Hammers LW, Hamper UM, Langer JE, Reading CC, Scoutt LM, Stavros AT. ACR Thyroid Imaging, Reporting and Data System (TI-RADS): White Paper of the ACR TI-RADS Committee. J Am Coll Radiol. 2017 May;14(5):587-595. doi: 10.1016/j.jacr.2017.01.046. Epub 2017 Apr 2.
- Results publication: PubMed 38372907de Carlos J, Garcia J, Basterra FJ, Pineda JJ, Dolores Ollero M, Toni M, Munarriz P, Anda E. Interobserver variability in thyroid ultrasound. Endocrine. 2024 Aug;85(2):730-736. doi: 10.1007/s12020-024-03731-5. Epub 2024 Feb 19.
- Results publication: PubMed 36909304Patel J, Klopper J, Cottrill EE. Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities. Front Endocrinol (Lausanne). 2023 Feb 24;14:1101410. doi: 10.3389/fendo.2023.1101410. eCollection 2023.
- Thyroid Cancer Diagnosis and Treatment GuidelinesLink provided by the sponsor.
- 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 Abnormalities and Thyroid, run by Second Affiliated Hospital of Nanchang University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Dec 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?
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?
Predictive Performance of Large Models in Ultrasound Thyroid Applications for Thyroid Diseases (time frame: Within 12 months of enrollment for each patient at the time of study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07296575, which also lists 3 linked publications.
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 22 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.