Pilot Study for the Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Changes in Thyroid Nodule Size
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
RFA Group
Intervention: RFA (Device)
Outcomes
Primary Outcomes
Changes in Thyroid Nodule Size
Time Frame: 24 months
Thyroid tumor volume shrinkage will be assessed by ultrasound and compared with pre-procedure volume (measure in mL)
Secondary Outcomes
- Pain Related to RFA Procedure(Up to 24 months)
- Development of Lymph Node Involvement(18 months)
- Development of Distant Metastasis(18 months)
- Safety of the RFA Procedure(Up to 24 months)
- Change in Thyroid Status(Up to 24 months)