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Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

Primary Purpose

Amiodarone-Induced Thyrotoxicosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RFA
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amiodarone-Induced Thyrotoxicosis focused on measuring Hyperthyroidism, RFA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RFA group

Arm Description

RFA

Outcomes

Primary Outcome Measures

Free T4 Response Post RFA
Thyroid tests
Total T3 Response Post RFA
Thyroid tests

Secondary Outcome Measures

Pain Related to RFA Procedure
McGill Pain Questionnaire
Thyroid-stimulating Hormone (TSH) Response Post RFA
Thyroid tests

Full Information

First Posted
October 17, 2018
Last Updated
September 11, 2021
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03720210
Brief Title
Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis
Official Title
Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Very low enrollment
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amiodarone-Induced Thyrotoxicosis
Keywords
Hyperthyroidism, RFA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label single interventional series
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFA group
Arm Type
Experimental
Arm Description
RFA
Intervention Type
Device
Intervention Name(s)
RFA
Intervention Description
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Primary Outcome Measure Information:
Title
Free T4 Response Post RFA
Description
Thyroid tests
Time Frame
3 - 6 months
Title
Total T3 Response Post RFA
Description
Thyroid tests
Time Frame
3 - 6 months
Secondary Outcome Measure Information:
Title
Pain Related to RFA Procedure
Description
McGill Pain Questionnaire
Time Frame
1 - 2 months
Title
Thyroid-stimulating Hormone (TSH) Response Post RFA
Description
Thyroid tests
Time Frame
3 - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius N Stan, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

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