Thermal Ablation of Cervical Metastases From Thyroid Carcinoma (NCT04522570) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
Brazil84 participantsStarted 2020-12-14
Plain-language summary
This study will evaluate the clinical response and safety of ultrasound guided percutaneous thermal ablation of lymph node metastases from thyroid carcinoma as an alternative to surgical treatment.
The ablation of cervical lymph node metastases from differentiated thyroid carcinoma or medullary thyroid carcinoma will be directed to lesions larger than 0.8 cm, using ultrasound-guided radiofrequency ablation (RFA), laser ablation (LA) or cryoablation (Cryo) techniques, randomly assigned. Clinical and ultrasound monitoring will be carried out during 24 months, with examinations before the ablation procedure, immediately after including contrast-enhanced ultrasound (CEUS) when applicable, and B-mode, color Doppler and Shear-Wave elastography ultrasound follow up with 6, 12, and 24 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Patients with fine needle aspiration biopsy (FNAb)-proven metastatic cervical lymph nodes at levels I, II, III, IV, V, VI or VII from differentiated thyroid carcinoma or medullary thyroid carcinoma who underwent total thyroidectomy and subsequent radioiodine therapy, in case of differentiated thyroid carcinoma.
* Patients considered high surgical risk candidate or patients who are informed about the ablation therapy and prefers it instead surgery;
* Patients with metastatic cervical lymph nodes over 0.8 cm diameter and under 4.0 cm diameter; no more than 6 simultaneous cervical nodal metastases;
* Cervical recurrences in previously lateral neck dissection patients for differentiated thyroid carcinoma or medullary thyroid carcinoma over 0.8 cm diameter.
Exclusion Criteria:
* Age under 18 years
* Uncorrectable coagulopathy;
* Inconclusive or benign cytologic specimens;
* Pregnancy or breast-feeding;
* Anaplastic or poor-differentiated thyroid carcinoma;
* Partial thyroidectomy
* Cervical tumors not considered to surgery (invading vessels, nerves, larynx or trachea);
* Serious medical illness, including any of the following: uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the baseline visit, uncontrolled congestive heart failure;
* Participation in other studies that could affect the primary endpoint
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of technical feasibility
Timeframe: immediately after the procedure
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases