Treatment of Papillary Thyroid Carcinoma With Radiofrequency Ablation

November 28, 2023 updated by: Marius Stan, Mayo Clinic

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA Group
Device: RFA
Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in thyroid nodule size (overall volume measured in percentage)
Time Frame: 18 months
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
Time Frame: 1-2 months
McGill Pain Questionnaire (Pain intensity scale: 0 = none, 1 = mild, 2 = moderate or 3 = severe)
1-2 months
Development of lymph node involvement
Time Frame: 18 months
Cervical adenopathy
18 months
Development of distant metastasis
Time Frame: 18 months
Distant metastatic sites
18 months
Safety of the RFA procedure
Time Frame: 1-2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Marius Stan, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 16, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-005486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papillary Thyroid Cancer

Clinical Trials on RFA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe