Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules
1 other identifier
observational
600
1 country
2
Brief Summary
To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2024
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
February 14, 2025
February 1, 2025
4.1 years
December 7, 2024
February 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
volume reduction rate
The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume
through study completion, an average of 6 months
Secondary Outcomes (7)
rate of complications
1 week
rate of nodule regrowth
through study completion, an average of 6 months
rate of change of thyroid function
through study completion, an average of 6 months
rate of delayed surgery
through study completion, an average of 1 year
cosmetic score
through study completion, an average of 6 months
- +2 more secondary outcomes
Study Arms (1)
ultrasound-guided thermal ablation
ultrasound-guided thermal ablation
Interventions
microwave ablation, radio frequency ablation, laser ablation
Eligibility Criteria
patients with Bethesda III/IV thyroid nodules
You may qualify if:
- confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
- no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
- refusal or ineligibility for surgery
- follow-up time ≥12 months
You may not qualify if:
- follicular neoplasm or malignancy findings on biopsy
- no suspicious of malignancy in US
- patients with contra-lateral vocal cord paralysis
- follow- up time less than 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Chinese PLA General Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yukun Luo
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 7, 2024
First Posted
December 13, 2024
Study Start
December 9, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
February 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share