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Completed NCT04522570

Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

Conditions: Thyroid Neoplasia, Well-Differentiated Thyroid Cancer, Medullary Thyroid Cancer, Lymph Node Metastases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: Instituto do Cancer do Estado de São Paulo

Location: Instituto do Cancer do Estado de São Paulo São Paulo São Paulo

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04522570). StuddyBuddy aggregates publicly available trial information.