Clinical trial NCT03720210: Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis
Official title: Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amiodarone-Induced Thyrotoxicosis
Keywords: Hyperthyroidism
RFA
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single interventional series
Primary purpose: TREATMENT

Brief summary: Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Free T4 Response Post RFA
timeFrame: 3 - 6 months
measure: Total T3 Response Post RFA
timeFrame: 3 - 6 months
Secondary outcomes:
measure: Pain Related to RFA Procedure
timeFrame: 1 - 2 months
measure: Thyroid-stimulating Hormone (TSH) Response Post RFA
timeFrame: 3 - 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marius N Stan, MD
role: PRINCIPAL_INVESTIGATOR
References: