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Search / Trial NCT07042984

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

Launched by FUJIAN MEDICAL UNIVERSITY · Jun 21, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Ultrasound Radiomics Artificial Intelligence Ret Fusion Braf V600 E Lateral Neck Metastasis Deep Learning Model 11 Gene Panel

ClinConnect Summary

This clinical trial is studying a new way to predict certain genetic changes in thyroid cancer using ultrasound images. Specifically, it focuses on papillary thyroid cancer, a common type of thyroid tumor. Some of these cancers have changes in a gene called RET, which can affect how doctors decide to treat the cancer. Right now, testing for these gene changes can be expensive and isn’t always done, so some cases might be missed. This study uses a computer program that looks at routine ultrasound pictures of the thyroid to guess whether the tumor has the RET gene change and if the cancer has spread to nearby lymph nodes in the neck.

Adults aged 18 to 75 who have ultrasound results suggesting papillary thyroid cancer and are scheduled for thyroid surgery may be eligible to join. Participants will have a regular ultrasound and a standard needle biopsy to collect cells for gene testing, which is done quickly. The computer program will analyze the ultrasound images quietly in the background, but doctors won’t see its predictions during treatment. After surgery, researchers will compare the computer’s guesses with the gene test and final pathology results to see how accurate it is. There is no extra risk beyond the usual tests, and the study could help develop faster, less costly ways to identify higher-risk thyroid cancers in the future.

Gender

ALL

Eligibility criteria

  • 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.

About Fujian Medical University

Fujian Medical University is a prestigious academic institution located in Fujian Province, China, dedicated to advancing medical education, research, and clinical practice. With a strong emphasis on innovative healthcare solutions, the university actively engages in clinical trials to explore new therapeutic interventions and improve patient outcomes. Its comprehensive research programs are supported by a team of experienced professionals and state-of-the-art facilities, enabling the university to contribute significantly to the global medical community. Through its commitment to excellence and collaboration, Fujian Medical University aims to enhance the quality of healthcare delivery both locally and internationally.

Locations

Fuzhou, Fj, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported