Ultrasound-Guided Microwave Ablation Vs. Surgery for Low-Risk PapilaryThyroid Carcinoma

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Dec 5, 2024

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ClinConnect Summary

This clinical trial is studying two different treatment options for patients with low-risk papillary thyroid carcinoma (PTC), a common type of thyroid cancer. The researchers want to compare the effectiveness and safety of a procedure called ultrasound-guided microwave ablation (MWA) with traditional surgery. They are also looking at how certain genetic factors might influence which treatment is best for patients. The study is taking place at Sun Yat-sen Memorial Hospital from January 2022 to November 2024 and aims to gather long-term data on patients' health after treatment.

To join the trial, participants need to be diagnosed with low-risk PTC, which means their cancer is small (less than 1 cm), has not spread, and shows specific low-risk genetic markers. They should not have serious health issues that could complicate treatment and must be able to provide complete follow-up information. Those who take part will undergo genetic testing and then receive either MWA or surgery, with their health monitored over time to see how well the treatments work and any side effects they may experience. This study could help provide better treatment options for patients with low-risk thyroid cancer in the future.

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Eligibility criteria

• The inclusion criteria of this study were as followed:
• • 1. PTC confirmed by fine-needle aspiration (FNA);
• • 2. Confirmed low-risk mutation types by next-generation sequencing (NGS) before surgery;
• • 3. No severe functional diseases, such as heart failure, severe respiratory diseases, or renal failure;
• • 4. Availability of complete follow-up data.
• The exclusion criteria were as followed:
• • 1. No local or distant metastasis assessed by imaging evaluations, including ultrasound or computed tomography (CT);
• • 2. Lacking of preoperative genetic testing or inability to assess genetic test results;
• • 3. Inability to complete follow-up or lost to follow-up during the study.
• Low-risk PTC is defined as:
• • 1. Maximum tumor diameter ≤1 cm;
• • 2. Solitary lesion;
• • 3. No local or distant metastasis;
• • 4. No tumor invasion into extrathyroidal tissues;
• • 5. No vascular invasion;
• • 6. Non-invasive pathological subtype for the primary lesion (invasive subtypes include tall cell, columnar cell, diffuse sclerosing, solid/trabecular, and oncocytic vari ants);
• • 7. No history of head and neck radiotherapy during adolescence;
• • 8. No family history of thyroid cancer;
• • 9. Genetic testing showing BRAF V600E mutation (without concurrent TERT mutation), RAS family gene mutations, (HRAS, NRAS, KRAS), or other low-risk mutations, such as isolated RET/PTC) rearrangements.
• Intermediate-high risk PTC is defined as:
• • 1. Maximum tumor diameter \>1 cm;
• • 2. Multifocal thyroid cancer;
• • 3. Local or distant metastasis;
• • 4. Primary lesion with extrathyroidal extension;
• • 5. Vascular invasion;
• • 6. Primary lesion with an invasive pathological subtype;
• • 7. History of head and neck radiotherapy during adolescence;
• • 8. Family history of thyroid cancer;
• • 9. Genetic testing revealing high-risk mutation combinations, such as BRAF V600E or RAS mutations with concurrent TERT or TP53 mutations, or RAS mutations combined with EIF1AX mutations.