Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03720210
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Amiodarone-Induced Thyrotoxicosis	Device: RFA	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open label single interventional seriesOpen label single interventional series
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
• Actual Study Start Date: Nov 19, 2018
• Actual Primary Completion Date: Dec 7, 2020
• Actual Study Completion Date: Dec 7, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Free T4 Response Post RFA [3 - 6 months]

   Thyroid tests

2. Total T3 Response Post RFA [3 - 6 months]

   Thyroid tests

Secondary Outcome Measures

1. Pain Related to RFA Procedure [1 - 2 months]

   McGill Pain Questionnaire

2. Thyroid-stimulating Hormone (TSH) Response Post RFA [3 - 6 months]

   Thyroid tests

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 29, 2018

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Marius Stan, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03720210
• Other Study ID Numbers: 18-004450
• First Posted: Oct 25, 2018
• Last Update Posted: Oct 11, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Marius Stan, Principal Investigator, Mayo Clinic: Hyperthyroidism; RFA
• Additional relevant MeSH terms: Thyrotoxicosis

Study Results

Participant Flow

Arm/Group Title	RFA Group
Arm/Group Description	RFA (Radiofrequency Ablation) RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Period Title: Overall Study
STARTED	1
COMPLETED	0
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Overall Participants	1
Age, Customized (Count of Participants)
Age 31	1 100%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 100%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Free T4 Response Post RFA
Description	Thyroid tests
Time Frame	3 - 6 months

Outcome Measure Data

Analysis Population Description

The one subject enrolled did not return for follow up. Data not collected or analyzed.

Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Measure Participants	0

2. Primary Outcome

Title	Total T3 Response Post RFA
Description	Thyroid tests
Time Frame	3 - 6 months

Outcome Measure Data

Analysis Population Description

The one subject enrolled did not return for follow up. Data not collected or analyzed.

Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Measure Participants	0

3. Secondary Outcome

Title	Pain Related to RFA Procedure
Description	McGill Pain Questionnaire
Time Frame	1 - 2 months

Outcome Measure Data

Analysis Population Description

The one subject enrolled did not return for follow up. Data not collected or analyzed.

Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Measure Participants	0

4. Secondary Outcome

Title	Thyroid-stimulating Hormone (TSH) Response Post RFA
Description	Thyroid tests
Time Frame	3 - 6 months

Outcome Measure Data

Analysis Population Description

The one subject enrolled did not return for follow up. Data not collected or analyzed.

Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Measure Participants	0

Adverse Events

Time Frame	Adverse events were collected from RFA procedure to 72 hours post RFA procedure.
Arm/Group Title	RFA Group
Arm/Group Description	RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
All Cause Mortality
	RFA Group
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	RFA Group
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	RFA Group
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

Lack of interested & suitable candidates. The one subject enrolled was lost to follow up.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.