Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule

April 8, 2024 updated by: M.D. Anderson Cancer Center

Radiofrequency Ablation Use in Thyroid Nodule

This phase IV trial studies the effect of radiofrequency ablation in treating patients with benign or low risk thyroid nodule. Radiofrequency ablation uses a needle to deliver a high-frequency electric current to kill tumor cells by heating them. The goal of this research study is to learn if ultrasound guided radiofrequency ablation can provide the same treatment result as standard surgical removal of the thyroid nodule, small primary thyroid, or thyroid cancers that have come back. Researchers also want to learn if the procedure can be less invasive and perhaps provide a better recovery response than surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate the longitudinal thyroid nodule volume changes induced by radiofrequency ablation (RFA) during post procedure follow-up.

SECONDARY OBJECTIVES:

I. Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.

II. Evaluate the sonographic features of the nodule induced by RFA.

III. Compare cost of ultrasound guided RFA to gold standard surgical thyroidectomy.

OUTLINE:

Patients undergo ultrasound guided RFA over 1-2 hours.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Kim O. Learned, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is older than 18 years, is not a surgical candidate or refuses to have surgery
  • Patient is medically fit to undergo local anesthesia with or without conscious sedation
  • Patient is able to understand and give consent to participation in the study
  • Presence of compression symptoms or cosmetic concerns for which patient request treatment of the benign thyroid nodule
  • Solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter
  • Benign nodule is >= 2 cm in the largest dimension, and has either solid, or predominantly solid composition (>= 70% volume) without large calcification. Nodule is confirmed as benign (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB) or a single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features (American College of Radiology [ACR] Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion) within 6 months of planned RFA
  • Indeterminate thyroid nodule (atypical cells of undetermined significance [ACUS], follicular neoplasm), papillary thyroid carcinoma (PTC) without metastasis or locally recurrent thyroid cancer < 2 cm in the largest dimension. Nodule cytology is confirmed on a single FNA or CNB when the nodule has concordant ultrasound features (ACR TI-RAD TR 4-5, ATA intermediate-high suspicion) within 6 months of planned RFA
  • Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component
  • Selected nodule is amenable to trans-isthmus approach
  • Normal complete blood count, blood coagulation, serum levels of thyroid hormones, thyrotropin (TSH), calcitonin, and absence of anti-thyroglobulin antibodies (TgAb) and anti-thyroid peroxidase antibodies (TPOAb)
  • Patient agrees to participate in the clinical study and to complete all required visits and evaluations
  • Negative serum or urine pregnancy test for females of childbearing potential at base line pre-procedure evaluation

Exclusion Criteria:

  • Patients with cardiac arrhythmia and/or implanted cardiac device
  • Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings
  • History of neck radiation therapy
  • Pregnancy
  • Allergies to medications for anesthesia
  • Primary thyroid PTC with aggressive histology (tall cell, columnar cell, insular, e.g.) in consultation with cytology, endocrine and surgery team
  • Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease
  • Cystic nodules (< 70% solid components)
  • Calcified nodules
  • Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve
  • Patients with contralateral vocal cord paralysis
  • Uncorrectable coagulopathy with partial thromboplastin time (PTT) > 1.5 x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5 or platelet count <100,000 per mm^3

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (RFA)
Patients undergo ultrasound guided RFA over 1-2 hours.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Radiofrequency Ablation
Undergo RFA
Other Names:
  • RFA
  • Ablation, Radiofrequency
  • Radiofrequency Interstitial Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in thyroid nodule size
Time Frame: Baseline up to 12 months
The change from baseline to follow-up will be evaluated using Wilcoxon signed-rank tests. Additionally, will assess the association between changes in the nodule volume and covariates of interest, including but not excluded to the percentage of volume ablated, the nodule composition at treatment and follow-up, and the amount of energy delivered in Joules.
Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response that affect quality of life
Time Frame: Up to 12 months post-treatment
Will compare symptom scores and cosmetic grades to baseline using Wilcoxon signed-rank tests at both 6 months and at 12 months of follow-up.
Up to 12 months post-treatment
Sonographic features of nodules
Time Frame: Up to 12 months post-treatment
Sonographic features will be summarized descriptively.
Up to 12 months post-treatment
Cost of ultrasound-guided radiofrequency ablation (RFA)
Time Frame: Up to 12 months post-treatment
The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.
Up to 12 months post-treatment

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Kim O Learned, M.D. Anderson Cancer Center

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)

August 29, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0542 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-08354 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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