Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

September 11, 2021 updated by: Marius Stan, Mayo Clinic

Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RFA group
RFA
Device: RFA
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Free T4 Response Post RFA
Time Frame: 3 - 6 months
Thyroid tests
3 - 6 months
Total T3 Response Post RFA
Time Frame: 3 - 6 months
Thyroid tests
3 - 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Related to RFA Procedure
Time Frame: 1 - 2 months
McGill Pain Questionnaire
1 - 2 months
Thyroid-stimulating Hormone (TSH) Response Post RFA
Time Frame: 3 - 6 months
Thyroid tests
3 - 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Marius N Stan, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2018

Primary Completion (ACTUAL)

December 7, 2020

Study Completion (ACTUAL)

December 7, 2020

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (ACTUAL)

October 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2021

Last Update Submitted That Met QC Criteria

September 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-004450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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