Status:
ACTIVE_NOT_RECRUITING
Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Thyroid Neoplasia
Well-Differentiated Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. T...
Detailed Description
Thyroidectomy is the main treatment of well differentiated thyroid carcinoma. Residual or recurrent cervical metastases are common (9-20% of patients during long-term follow up). Thermal ablation of c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04522570
Start Date
December 14 2020
End Date
November 30 2026
Last Update
April 30 2025
Active Locations (1)
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1
Instituto do Cancer do Estado de São Paulo
São Paulo, Brazil, 01246000