Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Mayo Clinic

Status: Completed

Conditions: Papillary Thyroid Microcarcinoma; Papillary Thyroid Cancer

Treatments: Device: RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT04129411

19-005486

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

RFA Group

Experimental group

Treatment:

Device: RFA