Condition: Thyroid Cancer Patients · Lymph Node Metastasis · Sponsor: Tian'an Jiang
This is a single-arm, open-label, multicenter, exploratory clinical trial designed to systematically evaluate the efficacy, safety, and patient benefit of ultrasound-guided irreversible electroporation (IRE) ablation for recurrent or metastatic cervical lymph node disease in patients with thyroid cancer after prior curative thyroid surgery and neck dissection. A total of 85 participants will be enrolled. After providing written informed consent, participants will enter a screening period of up to 28 days. During screening, baseline imaging of target lymph nodes will be performed (contrast-enhanced ultrasound or computed tomography), and patient-reported and clinician-reported assessments will be completed, including quality of life, pain, neck appearance, and, when applicable, voice-related outcomes. Laboratory testing and immunology samples will also be collected. Eligible participants will undergo the first IRE ablation on Day 0 under ultrasound guidance. Acute pain will be assessed using the Numeric Rating Scale (NRS) at 0, 4, 8, 24, 48, and 72 hours after the procedure, and all adverse events and device deficiencies will be recorded. The first imaging re-assessment will be performed at Day 30 (±7 days). If residual enhancement suggests incomplete ablation, one salvage IRE ablation may be performed within 14 days. After confirmation of no need for salvage ablation or after completion of salvage ablation, participants will enter follow-up. Follow-up visits will occur eve…
This description comes directly from the study's public registry record.
Huiyang Wang · +86-18506823597 · 909927877@qq.com
Always discuss trial participation with your own doctor first.
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang, China | Recruiting |
| Zhejiang Cancer Hospital | Hangzhou, Zhejiang, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07328243