Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Are adults
Nodule with Papillary thyroid carcinoma meeting the below criteria:
- Diagnosed by fine needle aspiration (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.

Arm && Interventions

Group	Intervention	Description
RFA Group	RFA	-

Primary Outcome Measures

Name	Time	Method
Changes in Thyroid Nodule Size	24 months	Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)

Secondary Outcome Measures

Name	Time	Method
Change in Thyroid Status	Up to 24 months	Participants were tracked for thyroid status following radiofrequency ablation
Development of Lymph Node Involvement	18 months	Assessed by the number of participants with cervical adenopathy (enlargement of lymph nodes in the neck area). Participants will be evaluated during follow-up visits.
Development of Distant Metastasis	18 months	Assessed by the number of participants with distant metastasis if regional neck metastasis is detected on follow up.
Pain Related to RFA Procedure	Up to 24 months	Assessed by number of participants that reported any pain related to RFA procedure
Safety of the RFA Procedure	Up to 24 months	Assessed by the number of participants who experienced infection, hematoma, bruising, or other complications at the RFA site.