Thyroid CancerNCT06498674
AI-Assisted Ultrasound Review Before Thyroid Surgery
A study testing Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review in people with Thyroid Cancer and Thyroid Nodule, run by Fujian Medical University at 1 site in China.
Trial summary
This prospective, single-center, single-arm study evaluates a locked artificial intelligence (AI) system as a surgeon-led second-read tool before thyroid surgery. Eligible participants scheduled for thyroid surgery undergo standard ultrasonography followed by a standardized AI-assisted repeat examination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- What is being tested?
- Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 15 Oct 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with preoperative pathological confirmation of thyroid malignant tumors undergoing surgical treatment.
- Patients with benign thyroid tumors, such as thyroid adenomas causing compressive symptoms, undergoing surgical treatment.
- Patients with complete and high-quality traditional two-dimensional color ultrasound images.
- Complete postoperative pathology reports.
- Willingness to participate in this clinical trial and signing of informed consent.
Who cannot join
- Patients with a history of neck surgery or radiotherapy.
- Patients with a history of malignant tumors in other parts of the body.
- Patients with thyroid dysfunction.
- Incomplete or poor-quality traditional two-dimensional color ultrasound images.
- Incomplete postoperative pathology reports.
- Refusal to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
This prospective, single-center, single-arm study evaluates a locked artificial intelligence (AI) system as a surgeon-led second-read tool before thyroid surgery. Eligible participants scheduled for thyroid surgery undergo standard ultrasonography followed by a standardized AI-assisted repeat examination. The AI system evaluates thyroid nodules only; cervical lymph nodes are assessed by clinicians. The study assesses participant-level supplementary pathological examinations and treatment-decision changes and evaluates nodule-level diagnostic performance against final surgical histopathology.
Read the detailed description
This prospective, single-center, single-arm study evaluates a locked AI-assisted ultrasound system used during surgeon-led preoperative review in participants scheduled for thyroid surgery. Each participant undergoes standard preoperative ultrasonography followed by a standardized AI-assisted repeat examination. The locked system provides thyroid-nodule malignancy scores and classifications; it was not retrained or recalibrated during the study and did not assess cervical lymph nodes. Clinicians integrate standard ultrasound, cytology, clinical findings, and other information and retain responsibility for all supplementary examinations and final management decisions. The two primary outcomes are participant-level: (1) whether a participant undergoes an additional cytologic or pathologic examination and (2) whether a participant has at least one change in planned surgical management. Participants are counted once within each outcome, while event counts may be summarized separately. The embedded diagnostic analysis is nodule-level and uses unambiguously pathology-matched surgical histopathology as the reference standard. Only nodules with a definitive benign or malignant surgical histopathological diagnosis are included in binary diagnostic-performance calculations. Low-risk or borderline thyroid neoplasms, including follicular tumors of uncertain malignant potential (FT-UMP), well-differentiated tumors of uncertain malignant potential (WDT-UMP), and non-invasive follicular thyroid neoplasms with papillary-like nuclear features (NIFTP), and nodules without unambiguous lesion-level linkage are excluded from binary reference-standard analyses. These post-enrollment analysis exclusions do not alter the 515-participant actual enrollment or the participant-level workflow cohort. A participant may contribute another eligible nodule if that lesion has an unambiguous definitive diagnosis. Cervical lymph-node pathology is described only for nodes actually removed or sampled; no reference diagnosis is assigned to unsampled nodes.
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review
- Keywords
- Thyroid Cancer, Artificial Intelligence, Ultrasound, Preoperative Assessment
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locked AI-Assisted Thyroid Ultrasound Repeat Examination and ReviewDiagnostic test
After standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination. The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review. It did not assess cervical lymph nodes and was not retrained or recalibrated during the study. Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Preoperative Review | Experimental | Participants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output. The AI system does not assess cervical lymph nodes. All supplementary examinations and final diagnostic and surgical decisions are made by clinicians. Receives: Diagnostic Test: Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery. Each participant is counted once regardless of the number of examinations. The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
Measured: From completion of the AI-assisted repeat examination through completion of surgery
Proportion of Participants With a Change in Planned Surgical Management
Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed. Changes may involve thyroid resection or cervical lymph-node management. Each participant is counted once regardless of the number of changes. The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
Measured: From completion of the AI-assisted review through surgery
Secondary outcomes (13)
Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
Number and percentage of evaluated thyroid nodules in each clinician-assigned C-TIRADS category during conventional ultrasonography. Nodule size, composition, echogenicity, margins, calcifications, and clinician-assessed cervical lymph-node findings were recorded as descriptive covariates and were not treated as separate outcome measures.
Measured: During standard preoperative ultrasonography, before the AI-assisted repeat examination
Proportion of Evaluated Thyroid Nodules Classified as AI-Positive
Number and percentage of evaluated thyroid nodules with a locked AI malignancy score >0.5. The AI system evaluated thyroid nodules only and did not assess cervical lymph nodes.
Measured: During the preoperative AI-assisted repeat examination, before surgery
Results of Supplementary Cytologic or Pathologic Examinations
Among participants who underwent at least one additional cytologic or pathologic examination, record the cytologic or histopathologic result for each sampled thyroid nodule or cervical lymph node. Results are summarized at the examination level as nonmalignant, indeterminate, malignant, or metastatic, as applicable.
Measured: From supplementary sampling to availability of the corresponding result, before or during surgery
Final Histopathological Diagnosis of Resected Thyroid Nodules
For each resected thyroid nodule linked unambiguously to the evaluated lesion, record the final diagnosis as benign, malignant, follicular tumor of uncertain malignant potential (FT-UMP), well-differentiated tumor of uncertain malignant potential (WDT-UMP), non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP), or another borderline diagnosis.
Measured: From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Sensitivity of AI and C-TIRADS
Using definitive postoperative histopathology as the reference standard, sensitivity is TP/(TP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage. These lesion-level exclusions do not alter the 515-participant workflow cohort.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level False-Negative Rate of AI and C-TIRADS
For each method, the false-negative rate is FN/(TP + FN), expressed as a percentage, among definitively malignant thyroid nodules. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Positive Predictive Value of AI and C-TIRADS
For each method, positive predictive value is TP/(TP + FP), expressed as a percentage, among thyroid nodules classified as positive. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Youden Index of AI and C-TIRADS
For each method, the Youden index is sensitivity + specificity - 1 using fixed binary thresholds. AI positivity is defined as score >0.5; conventional ultrasound positivity is C-TIRADS category 4a or higher. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes
Among cervical lymph nodes actually removed or sampled and pathologically examined, record the number and percentage with and without metastasis. No pathologic reference diagnosis is assigned to unsampled lymph nodes.
Measured: From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Specificity of AI and C-TIRADS
Using definitive postoperative histopathology as the reference standard, specificity is TN/(TN + FP), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Negative Predictive Value of AI and C-TIRADS
Using definitive postoperative histopathology as the reference standard, negative predictive value is TN/(TN + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Accuracy of AI and C-TIRADS
Using definitive postoperative histopathology as the reference standard, accuracy is (TP + TN)/(TP + TN + FP + FN), expressed as a percentage, for the locked AI classification (positive if score >0.5) and conventional C-TIRADS (positive if category 4a or higher). Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Area Under the ROC Curve for the Continuous AI Malignancy Score
Using definitive postoperative histopathology as the reference standard, calculate the area under the receiver operating characteristic curve for the continuous locked AI malignancy score. Include only pathology-matched nodules with an unambiguous lesion-level link and a definitive benign or malignant diagnosis. Exclude FT-UMP, WDT-UMP, NIFTP, other borderline diagnoses, and nodules without unambiguous lesion-level linkage. No AUC is calculated for the single-threshold C-TIRADS classification.
Measured: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Sep 2024
- Primary completion28 Sep 2025
- Study completion15 Oct 2025
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.
- More trials run by Fujian Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants underwent the same surgeon-led workflow: standard preoperative ultrasound followed by review of a locked AI nodule-assessment output. Concordant and discordant findings were workflow strata, not assigned study arms. Additional pathological examination and management changes were clinician directed.
- Masking
- None (open label)
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498674
- Sponsor's protocol ID
- AI-base PCD
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for external sharing because the dataset contains detailed clinical records and ultrasound images that may remain re-identifiable, and the available study records do not document participant consent specifically permitting external IPD sharing or institutional authorization for such sharing. Aggregate, non-identifiable results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of AI-assisted Ultrasound Technology in the Preoperative Evaluation of Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06498674
- Acronym / sponsor ID
- AI-base PCD
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Keywords
- Thyroid Cancer, Artificial Intelligence, Ultrasound, Preoperative Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 28 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 12 Jul 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.
This prospective, single-center, single-arm study evaluates a locked artificial intelligence (AI) system as a surgeon-led second-read tool before thyroid surgery. Eligible participants scheduled for thyroid surgery undergo standard ultrasonography followed by a standardized AI-assisted repeat examination. The AI system evaluates thyroid nodules only; cervical lymph nodes are assessed by clinicians. The study assesses participant-level supplementary pathological examinations and treatment-decision changes and evaluates nodule-level diagnostic performance against final surgical histopathology.
Detailed description
This prospective, single-center, single-arm study evaluates a locked AI-assisted ultrasound system used during surgeon-led preoperative review in participants scheduled for thyroid surgery. Each participant undergoes standard preoperative ultrasonography followed by a standardized AI-assisted repeat examination. The locked system provides thyroid-nodule malignancy scores and classifications; it was not retrained or recalibrated during the study and did not assess cervical lymph nodes. Clinicians integrate standard ultrasound, cytology, clinical findings, and other information and retain responsibility for all supplementary examinations and final management decisions. The two primary outcomes are participant-level: (1) whether a participant undergoes an additional cytologic or pathologic examination and (2) whether a participant has at least one change in planned surgical management. Participants are counted once within each outcome, while event counts may be summarized separately. The embedded diagnostic analysis is nodule-level and uses unambiguously pathology-matched surgical histopathology as the reference standard. Only nodules with a definitive benign or malignant surgical histopathological diagnosis are included in binary diagnostic-performance calculations. Low-risk or borderline thyroid neoplasms, including follicular tumors of uncertain malignant potential (FT-UMP), well-differentiated tumors of uncertain malignant potential (WDT-UMP), and non-invasive follicular thyroid neoplasms with papillary-like nuclear features (NIFTP), and nodules without unambiguous lesion-level linkage are excluded from binary reference-standard analyses. These post-enrollment analysis exclusions do not alter the 515-participant actual enrollment or the participant-level workflow cohort. A participant may contribute another eligible nodule if that lesion has an unambiguous definitive diagnosis. Cervical lymph-node pathology is described only for nodes actually removed or sampled; no reference diagnosis is assigned to unsampled nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants underwent the same surgeon-led workflow: standard preoperative ultrasound followed by review of a locked AI nodule-assessment output. Concordant and discordant findings were workflow strata, not assigned study arms. Additional pathological examination and management changes were clinician directed.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Preoperative Review | Experimental | Diagnostic Test: Locked AI-Assisted Thyroid Ultrasound Repeat Examination and ReviewParticipants undergo standard preoperative thyroid ultrasonography followed by a standardized AI-assisted repeat examination and surgeon-led review incorporating the locked AI system's thyroid-nodule output. The AI system does not assess cervical lymph nodes. All supplementary examinations and final diagnostic and surgical decisions are made by clinicians. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with preoperative pathological confirmation of thyroid malignant tumors undergoing surgical treatment.
- Patients with benign thyroid tumors, such as thyroid adenomas causing compressive symptoms, undergoing surgical treatment.
- Patients with complete and high-quality traditional two-dimensional color ultrasound images.
- Complete postoperative pathology reports.
- Willingness to participate in this clinical trial and signing of informed consent.
Key exclusion criteria (6 listed)
- Patients with a history of neck surgery or radiotherapy.
- Patients with a history of malignant tumors in other parts of the body.
- Patients with thyroid dysfunction.
- Incomplete or poor-quality traditional two-dimensional color ultrasound images.
- Incomplete postoperative pathology reports.
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 |
|---|---|---|
| Locked AI-Assisted Thyroid Ultrasound Repeat Examination and ReviewAfter standard preoperative ultrasonography, the same participant underwent a standardized AI-assisted repeat examination. The locked system identified and classified thyroid nodules and provided malignancy-score information for surgeon-led review. It did not assess cervical lymph nodes and was not retrained or recalibrated during the study. Additional fine-needle aspiration, intraoperative pathologic examination, and surgical management were determined by clinicians using the complete clinical assessment. | Diagnostic test | AI-Assisted Preoperative Review |
Primary outcome
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination
Time frame: From completion of the AI-assisted repeat examination through completion of surgery
Number and proportion of enrolled participants who underwent at least one additional cytologic or pathologic examination, such as fine-needle aspiration or intraoperative frozen-section examination, after completion of conventional ultrasonography and AI-assisted review and before completion of surgery. Each participant is counted once regardless of the number of examinations. The decision remained clinician led; cervical lymph-node examinations were outside the AI system's task.
Proportion of Participants With a Change in Planned Surgical Management
Time frame: From completion of the AI-assisted review through surgery
Number and proportion of enrolled participants with at least one documented change in the surgeon-led planned surgical approach or extent after conventional ultrasonography, AI-assisted review, and any supplementary pathological examination, when performed. Changes may involve thyroid resection or cervical lymph-node management. Each participant is counted once regardless of the number of changes. The AI system provided thyroid-nodule information only and did not assess cervical lymph nodes.
13 secondary outcomes
Distribution of C-TIRADS Categories Among Evaluated Thyroid Nodules
Time frame: During standard preoperative ultrasonography, before the AI-assisted repeat examination
Proportion of Evaluated Thyroid Nodules Classified as AI-Positive
Time frame: During the preoperative AI-assisted repeat examination, before surgery
Results of Supplementary Cytologic or Pathologic Examinations
Time frame: From supplementary sampling to availability of the corresponding result, before or during surgery
Final Histopathological Diagnosis of Resected Thyroid Nodules
Time frame: From surgery until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Sensitivity of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level False-Negative Rate of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Positive Predictive Value of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Youden Index of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Distribution of Cervical Lymph-Node Metastasis Status Among Pathologically Examined Nodes
Time frame: From surgery or supplementary sampling until the corresponding pathology result became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Specificity of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Negative Predictive Value of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Nodule-Level Accuracy of AI and C-TIRADS
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
Area Under the ROC Curve for the Continuous AI Malignancy Score
Time frame: From the preoperative examinations until the final postoperative histopathology report became available; assessed through October 15, 2025, over the approximately 14-month study period.
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 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for external sharing because the dataset contains detailed clinical records and ultrasound images that may remain re-identifiable, and the available study records do not document participant consent specifically permitting external IPD sharing or institutional authorization for such sharing. Aggregate, non-identifiable results will be reported in publications.
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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?
A study testing Locked AI-Assisted Thyroid Ultrasound Repeat Examination and Review in people with Thyroid Cancer and Thyroid Nodule, run by Fujian Medical 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 7 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?
Proportion of Participants Undergoing Supplementary Cytologic or Pathologic Examination (time frame: From completion of the AI-assisted repeat examination through completion of surgery). 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 7 Aug 2026.