Actively Recruiting
Efficacy of Irreversible Electroporation Ablation for Postoperative Recurrent or Metastatic Cervical Lymph Node Disease in Thyroid Cancer: A Prospective, Multicenter, Single-Arm, Exploratory Clinical Trial
Led by Tian'an Jiang · Updated on 2026-01-09
85
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ultrasound-guided irreversible electroporation (IRE) ablation to treat recurrent or metastatic cervical lymph node disease in patients with thyroid cancer who have previously undergone thyroid surgery and neck dissection. This exploratory clinical trial aims to systematically assess the treatment's effectiveness, safety, and benefits for patients with this condition. A total of 85 participants will be enrolled to better understand outcomes after this specialized procedure. Participants will provide informed consent and then undergo a screening period lasting up to 28 days, which includes imaging of affected lymph nodes, quality of life questionnaires, pain and neck appearance assessments, voice evaluations when relevant, and laboratory testing. On Day 0, enrolled participants will receive the first ultrasound-guided IRE ablation targeting cervical lymph nodes. Imaging will be repeated about 30 days later to check for any remaining active tissue, with the option of one additional salvage ablation performed within 14 days if necessary. Following treatment, patients will enter a follow-up phase with visits every three months for up to two years or until disease progression, withdrawal, death, or loss to follow-up. During follow-up, researchers will conduct regular imaging to monitor lymph node changes and collect patient-reported outcomes on quality of life, neck appearance, and voice as needed. Laboratory and immune system testing will be done every three months. Key outcomes include measuring lymph node volume reduction at 12 months after ablation, disappearance and recurrence rates, survival outcomes, and safety regarding adverse events and pain levels. Exploratory analyses will study immune cell changes and serum markers. Adverse events will be tracked for 12 months after the last ablation procedure.
CONDITIONS
Brief Title
Irreversible Electroporation for Recurrent or Metastatic Cervical Lymph Node Metastases From Thyroid Cancer: A Prospective Multicenter Single-Arm Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signs a written informed consent form
- Age 18 years or older, male or female
- ECOG performance status score of 0 or 1
- Expected survival time of at least 12 months
- Cervical lymph node metastases confirmed by pathology with recurrent/metastatic thyroid cancer after standard thyroid lobectomy plus lymph node dissection
- No more than 5 lymph nodes on one side of the neck, each with a maximum long-axis diameter less than 3.0 cm
- Not suitable for repeat surgery or refuses repeat surgery, or radioactive iodine therapy is ineffective or refused
- Adequate organ function as defined by blood counts, kidney function, liver function, coagulation, and cardiac function
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and 180 days after treatment
- Male participants with female partners of childbearing potential must use effective contraception during and 180 days after treatment
- Willing and able to comply with study visits, treatment, and laboratory testing
You will not qualify if you...
- History of severe bleeding or coagulation disorders or significant bleeding within 1 month before treatment
- History of serious heart conditions including myocarditis, cardiomyopathy, unstable angina, recent heart attack, or heart failure
- Unable to cooperate with treatment or tolerate general anesthesia
- Presence of distant metastases outside the neck region
- Metastatic lymph nodes located in level VII of the neck
- Received radioactive iodine therapy within the past 6 months
- Allergy to ultrasound or CT contrast agents or unable to undergo contrast imaging
- Neck surgery, local ablation, chemotherapy, or immunotherapy/targeted therapy within past 3 months
- Unsafe to place ablation needles as judged by the investigator
- Presence of metallic implants or non-removable catheters in the neck affecting treatment
- Untreated malignant tumors or history of malignancy within past 5 years except certain skin or cervical cancers
- Concurrent participation in another clinical study
- History of psychiatric disorders, substance abuse, or illicit drug use
- Major surgery or severe trauma within 30 days before treatment or planned surgery within 30 days after
- Recent gastrointestinal bleeding, ulcers, severe COPD exacerbation, or other serious medical conditions
- Recent serious blood clots, stroke, or uncontrolled high blood pressure
- Any condition that could affect study results or participant safety as judged by the investigator
- Other conditions making participation unsuitable in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 44 days (Day 0 to up to 14 days after Day 30 imaging)
Participants undergo ultrasound-guided irreversible electroporation (IRE) ablation of target cervical lymph node(s) on Day 0. If incomplete ablation is suspected at Day 30 imaging, a salvage IRE ablation may be performed within 14 days.
1 ablation visit on Day 0 and 1 imaging visit at Day 30 (±7 days); 1 additional salvage ablation visit if needed within 14 days after Day 30
Duration - Up to 24 months
Participants are monitored for treatment outcomes including lymph node volume reduction, disappearance of treated nodes, recurrence rate, progression-free survival, and overall survival up to 24 months after the first IRE ablation.
Follow-up visits scheduled over 24 months post-treatment
Trial Site Locations
Total: 1 location
1
No. 79 Qingchun Road, Shangcheng District
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
Huiyang Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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