Clinical trial · Observational
RET-US Study - Ultrasound-Based Prediction of RET Alterations and Lateral-Neck Metastasis in Thyroid Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphatic Metastasis | — | UNRESOLVED | — |
| Papillary Thyroid Carcinoma | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
| RET Proto-Oncogene Mutation | — | UNRESOLVED | — |
| Thyroid Neoplasms | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Ultrasound RET Prediction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prospective Thyroid Cancer Cohort
- description
- Consecutive adults (18-75 y) with ultrasound-suspected papillary thyroid carcinoma scheduled for surgery. Each participant undergoes standard pre-operative ultrasound, rapid 14-gene next-generation sequencing (NGS) panel, and blinded AI analysis of the ultrasound images. No treatment allocation is made; data are collected prospectively to validate the AI model's ability to detect RET alterations and predict lateral-neck lymph-node metastasis.
- interventionNames
- Diagnostic Test: AI-Ultrasound RET Prediction
Primary outcomes (1)
- measure
- Area Under the ROC Curve (AUC) for AI-Ultrasound Detection of RET Alterations
- timeFrame
- Date of surgery (assessment completed when gene-panel result is available)
- description
- The receiver-operating-characteristic area under the curve comparing the AI-generated probability score against the reference 14-gene next-generation sequencing (NGS) result for RET fusion or point mutation. AUC calculated with 95 % confidence interval via DeLong method.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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. * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or other condition that precludes surgery or gene testing.
References
Publications (0)
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