Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Radiofrequency Ablation of Papillary Thyroid Microcarcinoma

Conditions
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Papillary Thyroid Cancer

Intervention / Treatment
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* Procedure: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency Ablation<br>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<br>* Radiofrequency Ablation using RFMedical device.<br>|

What is the study measuring?
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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 |