Evaluating thermal ablation and surgery for low-risk papillary thyroid cancer
The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma
This study is testing whether a new treatment using heat can be as effective as traditional surgery for people with low-risk thyroid cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3772 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06316895 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical outcomes of ultrasound-guided thermal ablation compared to traditional thyroid surgery for patients with low-risk papillary thyroid carcinoma. It will also focus on developing and validating an artificial intelligence model to predict the outcomes of thermal ablation in this patient population. The study will include patients aged 18 to 80 with confirmed papillary thyroid carcinoma and specific tumor characteristics, and will follow them for at least 12 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with low-risk papillary thyroid carcinoma that meets specific criteria.
Not a fit: Patients with aggressive forms of thyroid cancer or significant comorbidities 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 there have been studies on thermal ablation for thyroid conditions, the specific combination of AI prediction and low-risk papillary thyroid carcinoma treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients age between 18 and 80 year old, both sex 2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration 3. the largest diameter ≤2.0 cm 4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT 5. follow-up period ≥12 months, Exclusion Criteria: 1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy 2. history of neck radiation 3. history of thyroid surgery 4. coagulation disorder 5. serious heart, respiratory, liver, or renal failure 6. dysfunction of the vocal cord on the opposite side
Where this trial is running
Beijing
- Chinese PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Lin Yan, MD
- Email: gemma-y@163.com
- Phone: 13811237313
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.