Amiodarone-Induced ThyrotoxicosisNCT03720210
Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis
A study testing RFA in people with Amiodarone-Induced Thyrotoxicosis, run by Mayo Clinic at 1 site in United States.
Trial summary
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amiodarone-Induced Thyrotoxicosis
- What is being tested?
- RFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
Read the 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.
- Conditions
- Amiodarone-Induced Thyrotoxicosis
- Being tested
- RFA
- Keywords
- Hyperthyroidism, RFA
- Medical subject headings
- Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFADevice
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
| Study group | Role | What they receive |
|---|---|---|
| RFA group | Experimental | RFA Receives: Device: RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free T4 Response Post RFA
Thyroid tests
Measured: 3 - 6 months
Total T3 Response Post RFA
Thyroid tests
Measured: 3 - 6 months
Secondary outcomes (2)
Pain Related to RFA Procedure
McGill Pain Questionnaire
Measured: 1 - 2 months
Thyroid-stimulating Hormone (TSH) Response Post RFA
Thyroid tests
Measured: 3 - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start19 Nov 2018
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Why it stopped: Very low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amiodarone-Induced ThyrotoxicosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single interventional series
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Stan, Mayo Clinic
- Investigators
- Marius N Stan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720210
- Sponsor's protocol ID
- 18-004450
- Status last verified
- Sep 2021
- First submitted
- 17 Oct 2018
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT03720210
- Acronym / sponsor ID
- 18-004450
- Conditions
- Amiodarone-Induced Thyrotoxicosis
- Keywords
- Hyperthyroidism, RFA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 11 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single interventional series
| Arm | Type | Receives |
|---|---|---|
| RFA group | Experimental | Device: RFARFA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFARadiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis | Device | RFA group |
Primary outcome
Free T4 Response Post RFA
Time frame: 3 - 6 months
Thyroid tests
Total T3 Response Post RFA
Time frame: 3 - 6 months
Thyroid tests
2 secondary outcomes
Pain Related to RFA Procedure
Time frame: 1 - 2 months
Thyroid-stimulating Hormone (TSH) Response Post RFA
Time frame: 3 - 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Amiodarone-Induced Thyrotoxicosis
RecruitingObservational study
Thyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis
Graves Disease, Amiodarone-Induced Thyrotoxicosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius N Stan, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA in people with Amiodarone-Induced Thyrotoxicosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free T4 Response Post RFA (time frame: 3 - 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.