Study of Ultrasound-Guided Irreversible Electroporation Ablation for Recurrent or Metastatic Cervical Lymph Nodes in Thyroid Cancer After Surgery

What this Trial Is About

Researchers are investigating the use of ultrasound-guided irreversible electroporation IRE ablation to treat patients with recurrent or metastatic cervical lymph node disease from thyroid cancer after prior thyroid surgery and neck dissection. This single-arm, open-label, multicenter clinical trial aims to evaluate the efficacy, safety, and patient benefits of this treatment in 85 participants. Participants will first undergo a screening period of up to 28 days, which includes baseline imaging of lymph nodes using contrast-enhanced ultrasound or computed tomography, as well as patient and clinician assessments of quality of life, pain, neck appearance, and voice when applicable. Eligible participants will receive an initial ultrasound-guided IRE ablation on Day 0, followed by pain assessments at multiple times within 72 hours and imaging reassessment at Day 30. If incomplete ablation is suspected, one salvage IRE ablation may be performed within 14 days. Following treatment, participants will have follow-up visits every 3 months for up to 24 months or until disease progression or other endpoints occur. These visits include imaging assessments, patient-reported outcomes related to thyroid cancer symptoms and quality of life, clinician scar evaluations, laboratory tests, and immunology sample collection. The main measure is lymph node volume reduction rate at 12 months after ablation, with additional measures including survival, recurrence, safety, and immune system changes.

Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm Study