Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Study Overview
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Brief Summary
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Investigators intend to evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

Detailed Description
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Investigators plan to identify patients with small papillary thyroid carcinoma and subject such patients to radiofrequency ablation (RFA) therapy. Following RFA procedure patients will be monitored to study the changes in primary tumor volume, development of lymph node involvement, development of distant metastasis and changes in serum thyroid hormone levels. Investigators will also assess the stability of these changes (need for repeat therapy) and the safety of the RFA procedure.

Official Title
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Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Conditions
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Papillary Thyroid Cancer, Papillary Thyroid Microcarcinoma

Intervention / Treatment
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* Device: RFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are adults Nodule with Papillary thyroid carcinoma meeting the below criteria: Diagnosed by FNA cytology. Size < 1.5 cm Non-surgical therapy is considered acceptable by the treating physician Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication Exclusion Criteria: Clinical evidence for a multifocal papillary thyroid malignancy Clinical evidence for local or distant metastatic disease Pregnancy Vocal cord paralysis on contralateral side Coagulopathy or patients on anticoagulation therapy Patients with prior neck surgery or neck radiation Patients with neck anatomy that precludes easy access by RFA Patients with comorbidities deemed too high of a risk for general anesthesia Treatment with another investigational drug or intervention (within 6 weeks of planned RFA). Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Open label single interventional series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA Group<br> | Device: RFA<br>* Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in thyroid nodule size (overall volume measured in percentage) | Thyroid tumor volume shrinkage in percentage will be assessed by ultrasound and compared with pre-procedure volume. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related to RFA procedure | McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe) | 1-2 months | 
| Development of lymph node involvement | Cervical adenopathy | 18 months | 
| Development of distant metastasis | Distant metastatic sites | 18 months | 
| Safety of the RFA procedure | Evaluation of site of RFA for local complication and asses pain with McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe) | 1-2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RFA, Radiofrequency, Thyroid Cancer, Ablation techniques, Ultrasonography