RFA Treatment for Papillary Thyroid Microcarcinoma

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

RFA Treatment for Papillary Thyroid Microcarcinoma Cohort

Thyroid surgery has always been the mainstay of treatment for thyroid cancer. 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 cancer 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.

The purpose of this observational study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of Papillary Thyroid Microcarcinoma (PTMC) in patients that have already agreed to RFA procedure based on treating physician recommendation. This is a data collection study in which we ask participants to give us 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 tumor. 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

Differentiated thyroid cancer (DTC), which includes papillary and follicular cancer, comprises the vast majority (>90%) of all thyroid cancers. The yearly incidence has nearly tripled from 4.9 per 100,000 in 1975 to 14.3 per 100,000 in 2009. Almost the entire change has been attributed to an increase in the incidence of papillary thyroid cancer (PTC). This increase in incidence is likely driven by the diagnosis of small PTCs <1cm in size due to the increasing use of neck ultrasonography. In a study observing 1235 patients with small papillary thyroid cancer over 22 years, it was noted that at 10 years follow-up, only 8% had tumor enlargement of >3mm and 3.8% had novel lymph node metastases proving that the majority of these 'microcarcinomas' were low-risk and indolent in nature. In 2017, the US commissioned task force evaluating the risks and benefits of treatment of these small cancers concluded that surgical treatment of these microcarcinomas was associated with a low, but not negligible, risk of surgical complications: 2.12-5.93% risk of permanent hypoparathyroidism and 0.99-2.13% risk of permanent recurrent laryngeal nerve injury. In addition, 98.8% of patients treated with thyroidectomy received radioactive iodine that was associated with an excess absolute risk of 11.9 to 13.3 cancers per 10, 000 person-years for second malignancies. In accordance with these data, the most recent societal guidelines for management of thyroid nodules and differentiated thyroid cancer have favored less aggressive management of microcarcinomas, with active surveillance as a reasonable option for management. However, although this may appeal to a subset of individuals who are especially risk and surgery averse, many patients are still uncomfortable with observing 'cancer' and still opt for the least invasive approach to surgical treatment. Thyroid surgery has always been the mainstay of treatment for thyroid cancer. Although 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 cancer 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. In addition, RFA of other solid tumors is a commonly performed procedure in the United states and all RFA devices, including the device the investigators 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). Recently, a systematic review and meta-analysis of thermal ablation techniques for micropapillary carcinomas found that among 503 low risk PTCs in 470 patients, no patient experienced tumor recurrence or distant metastasis, 2 patients (0.4%) experienced lymph node metastasis, 1 patient (0.2%) developed a new PTMC, which was successfully treated by additional ablation, and 5 patients (1.1%) underwent delayed surgery after ablation, including the two patients with lymph node metastasis and three additional patients with unknown etiology. 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 (Anticipated)

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (>/= 18 years) who have a biopsy proven papillary thyroid microcarcinoma (PTMC, >/= 1.5cm in greatest diameter)

Description

Inclusion Criteria:

  • Adult patients (>/= 18 years)
  • Biopsy proven papillary thyroid microcarcinoma (>/= 1.5cm in greatest diameter, PTMC)
  • Either refuse surgery or are not good surgical candidates

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete sonographic disappearance (CD)
Time Frame: 12 months
Rate of complete sonographic disappearance of primary tumor s/p RFA
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 12 months
Procedural complications s/p RFA including but not limited to infection, bleeding, nerve injury, structural injury
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)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2026

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)

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

  • AAAT6770

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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