Evaluating ultrasound-guided thermal ablation for benign thyroid nodules
The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study
This study is testing if a new ultrasound-guided treatment can safely shrink benign thyroid nodules and help people feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06340945 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical outcomes of ultrasound-guided thermal ablation as a treatment for benign thyroid nodules. It will also focus on developing and validating an artificial intelligence model to predict the outcomes of this treatment. Participants will undergo thermal ablation, and their progress will be monitored over a follow-up period of at least six months. The study seeks to provide insights into the effectiveness and safety of this minimally invasive procedure.
Who should consider this trial
Good fit: Ideal candidates include individuals with confirmed benign thyroid nodules who experience cosmetic or symptomatic issues and are not suitable for surgery.
Not a fit: Patients with malignant findings on biopsy or those with specific ultrasound features indicating malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a less invasive option for patients with benign thyroid nodules, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promising results with ultrasound-guided thermal ablation for similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months Exclusion Criteria: 1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications 3. patients with cystic nodules 4. patients with contra-lateral vocal cord par- alysis 5. previous radiation to the head and neck 6. ; follow- up time less than 6 months
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: 8613811237313
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.