Comparing microwave ablation and surgery for low-risk papillary thyroid cancer
Ultrasound and Gene-Guided Microwave Ablation Versus Surgery for Low-Risk Papillary Thyroid Carcinoma: a Prospective Observational Cohort Study.
This study is testing whether microwave ablation is a safe and effective alternative to surgery for people with low-risk papillary thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 201 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06725576 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and prognosis of ultrasound-guided microwave ablation (MWA) compared to surgical treatment for patients with low-risk papillary thyroid carcinoma (PTC). It focuses on the role of genetic mutations in treatment selection, utilizing next-generation sequencing to confirm low-risk status before treatment. A total of 201 patients diagnosed with PTC will be monitored until November 2024, with efficacy and complications assessed through long-term follow-up using ultrasound techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with low-risk papillary thyroid carcinoma who have confirmed genetic mutations and no metastasis.
Not a fit: Patients with high-risk papillary thyroid carcinoma or those who have metastasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with low-risk papillary thyroid carcinoma, potentially improving recovery times and outcomes.
How similar studies have performed: While microwave ablation is gaining recognition, this study's specific focus on genetic mutations in low-risk PTC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Miaoyun Long, MD
- Email: longmy@mail.sysu.edu.cn
- Phone: 86-34070602
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.