Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Free T4 Response Post RFA
研究概览
简要总结
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.
详细描述
Investigators plan to identify patients with amiodarone-induced thyrotoxicosis (AIT) that failed to respond to medical therapy or have developed side effects from medical therapy or are considered high risk for such therapy.
These patients will be offered the option to undergo radiofrequency ablation (RFA) of a portion of the thyroid gland in order to decrease thyroid hormone production and/or to inactive the existing thyroid hormone store before their leakage into the circulation.
Investigators will follow these patients to assess their clinical response as well as their thyroid values. The safety of the procedure will also be assessed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults
- •Have overt thyrotoxicosis (within 2 weeks prior to enrollment)
- •Are receiving medical therapy for AIT
- •Are able to understand the study procedures and to comply with them for the entire length of the study
- •Have not normalized their thyroid levels after one month of standard therapy or
- •Have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with Congestive heart failure (CHF), tachyarrhythmias, hemodynamic instability or similar co-morbidities) after 2 weeks of standard therapy where additional medical therapy is deemed unlikely to be beneficial or with high risk of side-effects (e.g. hepatotoxicity of antithyroid medications, agranulocytosis of potassium perchlorate or ATD or fluid retention associated with steroids).
排除标准
- •Pregnancy
- •Patients with prior neck surgery or neck radiation
- •Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma
- •Patients on anticoagulation therapy
- •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.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
结局指标
主要结局
Free T4 Response Post RFA
时间窗: 3 - 6 months
Thyroid tests
Total T3 Response Post RFA
时间窗: 3 - 6 months
Thyroid tests
次要结局
- Pain Related to RFA Procedure(1 - 2 months)
- Thyroid-stimulating Hormone (TSH) Response Post RFA(3 - 6 months)