Ultrasound-guided thermal ablation for benign thyroid nodules
Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules: A Multicenter Study
This study tests whether a new ultrasound-guided heat treatment can safely shrink benign thyroid nodules and improve patients' experiences over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06729762 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term outcomes of ultrasound-guided thermal ablation as a treatment for benign thyroid nodules. It is a multicenter observational study that aims to predict clinical outcomes based on patient experiences and follow-up data. Participants will undergo thermal ablation and will be monitored for at least 12 months to assess the effectiveness and safety of the procedure.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed benign thyroid nodules who experience cosmetic or symptomatic issues and are not eligible for surgery.
Not a fit: Patients with malignant findings on biopsy or those with suspicious features on ultrasound will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive treatment option for patients with benign thyroid nodules, 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 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 or core-needle biopsy 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 ≥12 months Exclusion Criteria: 1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in US 3. patients with contra-lateral vocal cord paralysis 4. previous radiation to the head and neck 5. follow- up time less than 12 months
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yukun Luo — Chinese PLA General Hospital
- 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.