Ultrasound-guided thermal ablation for certain thyroid nodules
Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study
This study tests whether a special heat treatment using ultrasound can safely help people with certain thyroid nodules who can't or don't want to have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06733753 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term outcomes of ultrasound-guided thermal ablation specifically for thyroid nodules classified as Bethesda III or IV. It aims to predict clinical outcomes for patients who have confirmed nodules but are either refusing surgery or are ineligible for it. The methodology involves monitoring patients over a follow-up period of at least 12 months to assess the effectiveness and safety of the thermal ablation procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Bethesda III or IV thyroid nodules who have refused surgery or are not eligible for surgical intervention.
Not a fit: Patients with confirmed malignancy or those who do not have suspicious findings on ultrasound will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with Bethesda III/IV thyroid nodules, potentially avoiding surgery.
How similar studies have performed: While there is ongoing research in thermal ablation for thyroid nodules, this specific approach for Bethesda III/IV nodules is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test 2. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT 3. refusal or ineligibility for surgery 4. follow-up time ≥12 months Exclusion Criteria: 1. follicular neoplasm or malignancy findings on biopsy 2. no suspicious of malignancy in US 3. patients with contra-lateral vocal cord paralysis 4. follow- up time less than 12 months
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Chinese PLA General Hospital — Beijing, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Yukun Luo — Chinese PLA General Hospital
- Study coordinator: Lin Yan
- 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.