Tests an AI ultrasound model for RET gene changes in thyroid cancer
Tests an AI reading of thyroid ultrasound images in adults with papillary thyroid cancer.
Plain-language title generated from the registry record
Registry title: RET-US Study - Ultrasound-Based Prediction of RET Alterations and Lateral-Neck Metastasis in Thyroid Cancer
Key facts
- Where
- Fuzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07042984, who can take part
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Medical University
- Trial code
- NCT07042984
- Record updated
- 29 June 2025
- Original description
Why is this study being done? RET gene alterations occur in only 5-10 % of papillary thyroid cancers, but they can change how surgeons treat the disease. Gene testing is costly and not always performed, so many RET-positive tumours are missed. Researchers have built a computer program (artificial-intelligence or "AI" model) that reads routine thyroid ultrasound images and predicts whether the tumour carries a RET alteration and whether the cancer has already spread to lymph-nodes in the side of the neck.Read full original descriptionShow less
RET-US Cohort: Prospective Evaluation of an AI-Ultrasound Model for Detecting RET Gene Alterations and Predicting Lateral Cervical Lymph-Node Metastasis in Papillary Thyroid Carcinoma
Why is this study being done? RET gene alterations occur in only 5-10 % of papillary thyroid cancers, but they can change how surgeons treat the disease. Gene testing is costly and not always performed, so many RET-positive tumours are missed. Researchers have built a computer program (artificial-intelligence or "AI" model) that reads routine thyroid ultrasound images and predicts whether the tumour carries a RET alteration and whether the cancer has already spread to lymph-nodes in the side of the neck.
What will happen in this study?
About 800 adults who are scheduled for thyroid-cancer surgery will take part. Each participant will:
* have a standard pre-operative ultrasound exam (no extra scanning time), * give a routine fine-needle sample for a 14-gene panel test (results in 24 h), and * allow the AI model to analyse the ultrasound images in the background. Doctors making treatment decisions will not see the AI result. After surgery, the research team will compare the AI predictions with the gene-panel result and the final pathology report.
Main goal: To find out how accurately the AI model detects RET alterations. Secondary goals: To measure the model's ability to predict lymph-node spread, and to compare costs between ultrasound-only prediction and full gene testing.
Benefits and risks: Participants will receive the current standard of care; there is no added risk beyond the usual ultrasound and needle biopsy. The study could lead to faster, less expensive ways to identify high-risk thyroid cancers in the future.
Inclusion: Age 18-75 years, able to provide written informed consent; Pre-operative ultrasound findings highly suggestive of papillary thyroid carcinoma; Planned thyroidectomy (any extent) at a participating institution; Willing to undergo rapid 11-gene next-generation sequencing (NGS) panel and allow use of ultrasound DICOM images for AI analysis.
Exclusion: Prior thyroid or major neck surgery; Known medullary thyroid carcinoma, anaplastic carcinoma, or metastatic disease outside the neck; Multiple endocrine neoplasia (MEN) syndromes or clinical suspicion of multi-gland disease; Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or other condition that precludes surgery or gene testing; Pregnant or breastfeeding.