Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Changes in Thyroid Nodule Size
研究概览
简要总结
Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.
详细描述
Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy.
Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels.
Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults
- •Nodule with Papillary thyroid carcinoma meeting the below criteria:
- •Diagnosed by fine needle aspiration (FNA) cytology.
- •Size < 1.5 cm
- •Non-surgical therapy is considered acceptable by the treating physician
- •Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication
排除标准
- •Clinical evidence for a multifocal papillary thyroid malignancy
- •Clinical evidence for local or distant metastatic disease
- •Pregnancy
- •Vocal cord paralysis on contralateral side
- •Coagulopathy or patients on anticoagulation therapy
- •Patients with prior neck surgery or neck radiation
- •Patients with neck anatomy that precludes easy access by RFA
- •Patients with comorbidities deemed too high of a risk for general anesthesia
- •Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
结局指标
主要结局
Changes in Thyroid Nodule Size
时间窗: 24 months
Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)
次要结局
- Pain Related to RFA Procedure(Up to 24 months)
- Development of Lymph Node Involvement(18 months)
- Development of Distant Metastasis(18 months)
- Safety of the RFA Procedure(Up to 24 months)
- Change in Thyroid Status(Up to 24 months)