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Treatment of Neck Metastases from Thyroid Cancer by Ultrasound Guided Ablatio

Not Applicable
Conditions
Thyroid Gland Neoplasm
C04.588.322.894
Registration Number
RBR-4wzd8p
Lead Sponsor
Instituto do Câncer do Estado de São Paulo - ICESP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
Not specified
Target Recruitment
Not specified
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 thyroid carcinoma (well differentiated, papillary - PTC or medullary) who underwent total thyroidectomy and subsequent radioiodine therapy, in case of PTC; 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 metachronous cervical nodal metastases; Cervical recurrences in previously lateral neck dissection patients for well differentiated papillary 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

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Feasibility and safety evaluation of thermal ablation of thyroid carcinoma cervical lymph node metastases
Secondary Outcome Measures
NameTimeMethod
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