Treatment of Amiodarone-Induced Thyroiditis with Radiofrequency Ablation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004450
NCT ID: NCT03720210
Sponsor Protocol Number: 18-004450
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:
- 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.
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:
- 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.
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