Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Traditionally, surgery has been the standard recommendation for treating papillary thyroid cancer. The risk of surgery including permanent hoarseness, permanent hypocalcemia, a mid-cervical scar, and the potential for permanent hypothyroidism may be unacceptable for some patients, especially with low risk papillary thyroid carcinoma. The recent American Thyroid Association guidelines have proposed the option of active surveillance with low risk papillary thyroid cancer less than 210 mm. However, most patients find observation anxiety provoking knowing of having cancer. Radiofrequency ablation (RFA) of small low risk papillary thyroid cancer is a promising therapeutic modality for these patients that reduces the risks associated with surgery and the anxiety of taking a watchful approach. However, this technique has not been validated in the North American population.

The investigators aim to describe the investigators' initial experience with RFA of low risk papillary thyroid microcarcinoma (PTMC) compared to active surveillance (AS) done by Head and Neck Endocrine surgeons at Johns Hopkins Medical Institute.

Primary objective:

• To evaluate the safety, efficacy and oncological outcomes of the procedure.

Secondary objective:

• To determine the patient functional outcomes in comparison to the observational control.

Study Overview

• Status: Completed
• Conditions: Papillary Thyroid Cancer
• Intervention / Treatment: Procedure: Radiofrequency Ablation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21278
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients regardless of sex or race between the ages 18-100 with biopsy proven PTMC with a Bethesda V or VI pathology or indeterminate cytology on fine-needle aspiration cytology (FNAC) who are recommended for treatment (Bethesda III/IV).
• Solitary thyroid nodule <20mm in maximal dimension.
• No sonographic evidence of extrathyroidal invasion, lymph node metastases, or distant metastases.
• There must be at least 1 mm of normal tissue as a margin, without sonographic evidence of contact with the capsule.

Exclusion Criteria:

• Patients with other histological types of thyroid malignancy other than papillary thyroid cancer such as medullary carcinoma, Proto-oncogene serine/threonine kinase (BRAF) or Telomerase reverse transcriptase (TERT) mutations
• Clinically apparent multicentricity
• Lesions larger than 20 mm in maximum diameter.
• Recurrent laryngeal nerve palsy.
• Extension of nodule to posterior thyroid capsule.
• Ultrasound or other imaging studies revealing cervical lymph node involvement or distant metastases.
• Pregnancy.
• Pacemaker.
• Previous RFA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency Ablation; Patients will receive RFA as a one-time intervention, with a possible second treatment after 6 months if adequate resolution is not noted on ultrasound.	Procedure: Radiofrequency Ablation; Radiofrequency Ablation using RFMedical device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 6 months
Percentage change in nodule volume	This will assess the percentage change in nodule volume (cubic millimeters).	Baseline and 24 months
Change in voice related quality of life as assessed by the VHI-10	Change from baseline in Voice Handicap index (VHI-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 6 months
Change in voice related quality of life as assessed by the VHI-10	Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 12 months
Change in voice related quality of life as assessed by the VHI-10	Change from baseline in the VHI-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 24 months
Scar cosmesis score	Average score on Scar cosmesis assessment and rating (SCAR) scale. Score ranges from 0-15. Higher score indicates worse scar.	6 months
Scar cosmesis score	Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.	12 months
Scar cosmesis score	Average score on SCAR scale. Score ranges from 0-15. Higher score indicates worse scar.	24 months
Change in eating assessment score as assessed by the EAT-10	Change from baseline on Eating assessment tool (EAT-10) score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 6 months
Change in eating assessment score as assessed by the EAT-10	Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 12 months
Change in eating assessment score as assessed by the EAT-10	Change from baseline on EAT-10 score. Score ranges from 0-40. Higher score indicates worse symptoms.	Baseline and 24 months
Change in overall quality of life assessed by the PROMIS score	Change from baseline on Patient-Reported Outcomes Measurement Information System (PROMIS)-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.	Baseline and 6 months
Change in overall quality of life assessed by the PROMIS score	Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.	Baseline and 12 months
Change in overall quality of life assessed by the PROMIS score	Change from baseline on PROMIS-29 score. Score ranges from 0-100. Higher score indicates worse symptoms.	Baseline and 24 months
Number of complications	Counts of skin burn, hematoma and vocal cord palsy.	12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: RF Medical Co., Ltd
• Investigators: Principal Investigator: Jonathon Russell, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): November 19, 2024
• Study Completion (Actual): November 19, 2024

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases
• Other Study ID Numbers: IRB00236242

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