Radiofrequency Ablation for BIII Thyroid Nodules

May 27, 2026 updated by: Jennifer Kuo, Columbia University

Radiofrequency Ablation for Indeterminate Bethesda III Thyroid Nodules

The purpose of this observational chart review study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of indeterminate thyroid nodules before and after RFA procedure. This is a data collection study in which the investigators ask patients to give access to information generated before and after RFA treatment of their condition. The RFA procedure uses image guidance to place an electrode through the skin into the target area. In RFA, high-frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the United States, there is an estimated 10% lifetime probability for developing a thyroid nodule.

Up to 15% of these nodules will prove to be malignant. The incidence of thyroid cancer is increasing and is the third leading cause of cancer in women; accordingly, identification of a nodule

1 cm or larger in diameter often prompts a sophisticated diagnostic evaluation comprised of sonographic pattern risk assessment combined with fine needle aspiration biopsy (FNAB), which enables the assessment of cellular morphologic features that could not be identified by means of clinical assessment or imaging. Ultrasound-guided FNAB has been shown to accurately classify 62-85% of thyroid nodules as benign, thereby avoiding diagnostic surgery. Yet, 20-30% of aspirations still yield indeterminate cytologic findings: "atypia (or follicular lesion) of undetermined significance," "follicular neoplasm or suspicious for follicular neoplasm," and "suspicious for malignancy with a risk of malignancy ranging from 6-75%." Most patients with cytologically indeterminate nodules are referred for diagnostic thyroid surgery, but the majority prove to have benign disease. For these patients, thyroid surgery is unnecessary, yet it exposes them to 2-10% risk of serious surgical complications, and most would require thyroid hormone replacement therapy for life. Research in recent years has focused on the potential of molecular diagnostic approaches that could capitalize on increasing knowledge of the molecular etiology of thyroid nodules and the transcriptional and mutation landscape of thyroid cancers to augment diagnostic accuracy of FNABs. Most molecular profiling tests demonstrate a high sensitivity and negative predictive value that helps to decrease the number of benign nodules undergoing unnecessary diagnostic surgery. However, these classified benign nodules may continue to grow and ultimately may need to undergo surgery due to compressive symptoms. Although thyroid surgery has always been the mainstay of treatment for symptomatic nodular goiters, and is associated with excellent outcomes in experienced hands, thyroid surgery carries a low risk of complications that include recurrent or superior laryngeal nerve injury leading to voice changes, hypoparathyroidism, hypothyroidism with need for thyroid hormone supplementation, and unsightly scarring. Although many patients with thyroid cancers find these risks acceptable, these risks are sometimes less acceptable to patients with benign disease. In an era when the medical field is treating thyroid diseases less aggressively, there is a pressing need to identify approaches to treat indolent malignant disease less invasively.

Introduced in the early 2000s, ultrasound-guided percutaneous ablation of thyroid lesions has emerged as a potential alternative to surgery in patients with benign thyroid nodules. Of the myriad ablation methods, the most commonly used technique is radiofrequency ablation (RFA). An expanding body of evidence shows that radiofrequency ablation and other percutaneous interventions are effective treatments for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-70% with durable resolution of compressive and hyperthyroid symptoms. In addition, RFA has been used as an effective alternative treatment in the management of locally recurrent thyroid cancers in patients who are not good surgical candidates. Although these percutaneous techniques have been steadily.

gaining acceptance in Europe and Asia over the past 20 years, they have been slow to be adopted in the US. There remains a dearth of data regarding clinical experience in the United States and no randomized clinical trials have been performed evaluating RFA vs active surveillance for micropapillary carcinomas.

Study Type

Observational

Enrollment (Estimated)

50

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult patients (>/= 18 years) who have biopsy proven indeterminate thyroid nodules (Bethesda III only) that have been molecular profiled benign, who refuse to undergo or are not good candidates for surgical resection

Description

Inclusion Criteria:

  • Indeterminate Bethesda III nodules that have been molecularly profiled benign with either Afirma Genomic Sequencing Classifier (GSC) or ThyroSeq v3 tests

Exclusion Criteria:

  • cardiac arrthymias
  • 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
Group
Procedure: Radiofrequency Ablation
Ultrasound guided radiofrequency ablation (non-experimental)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nodule Volume
Time Frame: 12 months
((Volume (baseline) - Volume (12m))/Volume(baseline))*100
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 12 months
Incidence of procedural complications including but not limited to infection, bleeding, voice change, nerve damage
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 1, 2020

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT1979

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

No

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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