Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

Papillary Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04129411
• Other study ID #: 19-005486
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papillary Thyroid Cancer
• Papillary Thyroid Microcarcinoma
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Device:
• RFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain related to RFA procedure	McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)	1-2 months
Secondary	Development of lymph node involvement	Cervical adenopathy	18 months
Secondary	Development of distant metastasis	Distant metastatic sites	18 months
Secondary	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

External Links

•   Mayo Clinic Clinical Trials