Ultrasound Guided Percutaneous Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
研究概览
简要总结
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.
详细描述
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 cervical metastatic lymph nodes from thyroid carcinoma has been proposed in research centers as an option for the treatment of patients who remain with metastatic disease in cervical lymph nodes, despite thyroidectomy with or without neck dissection associated with radioiodine treatment. Potential advantages from percutaneous thermal ablation are related to less complication rates, less morbidity, possibility of outpatient treatment modality, and less global treatment costs when compared to the surgical approach.
Aims of the study:
- To evaluate safety and efficacy of ultrasound-guided thermal ablation in the treatment of cervical lymph node metastases from differentiated thyroid carcinoma
- To evaluate the best response to thermal ablation defined as lymph node reduction or volume stability after ablation
- To evaluate the CEUS patterns of lymph nodes before and after ablation
- To evaluate the elastography patterns of lymph nodes before and after ablation
- To evaluate the tumor marker response after ablation
- To evaluate the contribution of thermal ablation to decrease additional therapeutic procedures
- To compare differences between LA, RFA and cryoablation in terms of complications, side effects and tolerability
Patients with cervical metastatic lymph nodes from differentiated thyroid carcinoma or medullary thyroid carcinoma who meet the eligibility criteria and who have been determined to be an appropriate candidate for local ablation therapy will be offered enrollment into the study. Patients agreeing to participate will become subjects of the study if they read and sign an informed consent form.
Treatment will be performed using three different ablation technologies (laser ablation, RFA or cryoablation) in a randomly assignment fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
时间窗: up to 4 weeks post-ablation
Evaluation of minor and major complication rates, immediately after ablation; and one- and four-weeks post-ablation by telephone call. Minor and major complication rates \[Designed as a safety issue: Yes\]. The safety endpoint for this study is to assess the incidence and severity of procedure or device-related adverse events, as reported by the Common Terminology Criteria of Adverse Events - CTCAE V5. 2017 Version.
Evaluation of technical feasibility
时间窗: immediately after the procedure
defined as the ability to target the nodule and to perform ablation as preoperatively planned
次要结局
- Evaluation of elastography pattern after thermal ablation therapy(24 months)
- Evaluation of technical success(immediately after the procedure)
- Evaluation of contrast-enhanced ultrasound pattern after thermal ablation therapy(12 months)
- Best response to the thermal ablation therapy(24 months)
- Evaluation of tumor marker response(24 months)
- Evaluation of additional therapies(24 months)
- Outcomes among thermal ablation therapies(24 months)