Treatment of Amiodarone-Induced Thyroiditis with Radiofrequency Ablation

Overview

About this study

The purpose of this study is to analyze the changes in serum thyroid hormone levels in amiodone-induced thyroiditis (AIT) patients after radiofrequency ablation (RFA) therapy on a portion of thyroid parenchyma in order to safely decrease thyroid hormone levels into the normal range with resolution of thyrotoxicosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

We will enroll patients with AIT that meet all criteria 1 through 4 and then either criteria A or B as follows:

  1. Are adults,
  2. Have overt thyrotoxicosis (within 2 weeks prior to enrollment);
  3. Are receiving medical therapy for AIT;
  4. Are able to understand the study procedures and to comply with them for the entire length of the study.

and:

  • A. have not normalized their thyroid levels after one month of standard therapy; or
  • B. have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with 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).

Exclusion Criteria: 

All candidates meeting any of the following exclusion criteria at baseline will be excluded from study participation:

  1. Pregnancy;
  2. Patients with prior neck surgery or neck radiation;
  3. Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma;
  4. Patients on anticoagulation therapy;
  5. Patients with comorbidities deemed too high of a risk for general anesthesia;
  6. Treatment with another investigational drug or intervention (within 6 weeks of planned RFA);
  7. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements;
  8. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Marius Stan, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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