Thyroid Gland Neoplasm
Conditions
Interventions
Sponsors
Instituto do Câncer do Estado de São Paulo - ICESP
Fundação Faculdade de Medicina
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and safety evaluation of thermal ablation of thyroid carcinoma cervical lymph node metastases | — |
Secondary
| Measure | Time frame |
|---|---|
| Best response to the thermal ablation therapy, defined as a subject having local disease control related to lymph node volume reduction or volume stability in percentage will be assessed by ultrasound measurement in comparison to pre-treatment volume;Evaluation of contrast-enhanced ultrasound (CEUS) enhancement pattern after thermal ablation therapy in comparison to pre-treatment pattern;Evaluation of elastography enhancement pattern after thermal ablation therapy in comparison to pre-treatment pattern;Evaluation of tumor marker response after thermal ablation therapy in comparison to pre-treatment pattern, defined in negative thyroglobulin, calcitonin, or CEA levels or anti-thyroglobulin antibodies;Evaluation of adicional therapies expressed by the number of patients with additional therapies for persistent/recurrent local disease associated with the index tumor (s) under study or new cervical lymph node metastases.;Number of patients with complications, side effects and tolerability in each ablation technique | — |
Countries
Brazil
Contacts
Public ContactMaria Folgueira
Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq
Outcome results
None listed