RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study

March 20, 2023 updated by: Jennifer Kuo, Columbia University

Clinical Outcomes and Quality of Life Measures After Surgical Resection and Radiofrequency Ablation of Benign Thyroid Nodules

The purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (MNG) patients. This is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Benign multinodular goiter (MNG) refers to an enlarged thyroid gland with nodules within it, frequently owing to iodine deficiency. It is the most common endocrine disorder worldwide.

Significant growths of nodules can cause symptomatic compressive symptoms such as dysphagia, dyspnea, or vascular compression of the neck vessels. On occasion, these nodules can develop autonomy and secrete excess thyroid hormone (toxic multinodular goiter). Surgical resection has been the preferred treatment option for symptomatic multinodular goiters and addresses both compressive symptoms as well as hyperthyroidism, but is associated with small, but not negligible risk of nerve injury, hypoparathyroidism, and may confer a risk of hypothyroidism and dependence on thyroid hormone supplementation.

Thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for MNG. Monopolar radiofrequency ablation (RFA) is presently the best documented thermoablative technique. Although RFA of thyroid nodules specifically, is still considered investigational in the United States, RFA of thyroid nodules has been used by several centers globally (mainly in South Korea, Italy, China, and Austria) since 2006 with excellent clinical outcomes. In addition, RFA of other solid tumors is a commonly performed procedure in the United states and all RFA devices, including the device that we will use for the clinical care of these patients, are cleared by the FDA (New devices/technology to the market are approved, but devices that have a predicate device/technology that are already on the market only need to be cleared). In response to its increasing popularity, the Korean Society of Thyroid Radiology commissioned a Task Force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012, and these recommendations were recently revised in 2017 and the American Association of Clinical Endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (>/=18 years) with benign, non-functional benign thyroid nodules

Description

Inclusion Criteria:

  • Adult patients >/=18 years old with benign thyroid nodules

Exclusion Criteria:

  • cardiac arrhythmia
  • pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thyroidectomy
Patients with benign thyroid nodules who undergo surgical resection
Procedure: Thyroidectomy
Surgical Resection of thyroid nodules
RFA
Patients with benign thyroid nodules who undergo radiofrequency ablation
Procedure: Radiofrequency Ablation
Radiofrequency Ablation of thyroid nodules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Volume Change of Nodules
Time Frame: 6 months and 12 months
Percent Volume Change of Nodules
6 months and 12 months
Change in Thyroid Stimulating Hormone (TSH)
Time Frame: 6 months and 12 months
Change in serum TSH
6 months and 12 months
ThyPRO 39 Survey Score
Time Frame: 12 months
The Thypro 39 is a survey assessing quality of life in patients with thyroid disease. Scores range from 0-100 with a higher score indicating a worse outcome.
12 months

Collaborators and Investigators

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

Sponsor

Columbia University

Investigators

  • Principal Investigator: Jennifer H Kuo, MD MS, Columbia University

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.

General Publications

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)

August 30, 2019

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAS2141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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