RET-US Study - Ultrasound-Based Prediction of RET Alterations and Lateral-Neck Metastasis in Thyroid Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Pregnant or breastfeeding.

Trial design

Treatments tested in this trial

  • AI-Ultrasound RET Prediction

Treatment groups

800 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fujian Medical University

Lead sponsor

Fujian Medical University Union Hospital

Sponsor institution