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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05003856

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Thyroid Gland Neoplasm Recurrent Thyroid Gland Carcinoma Thyroid Gland Follicular Tumor of Uncertain Malignant Potential Thyroid Gland Nodule Thyroid Gland Papillary Carcinoma	Other: Quality-of-Life Assessment Procedure: Radiofrequency Ablation	Early Phase 1

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

Evaluate treatment response to compressive and/or cosmetic symptoms that affect patient's quality of life.
Evaluate the sonographic features of the nodule induced by RFA.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiofrequency Ablation Use in Thyroid Nodule

Actual Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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: Ablation, Radiofrequency Radiofrequency Interstitial Ablation RFA

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:

Ablation, Radiofrequency

Radiofrequency Interstitial Ablation

RFA

Outcome Measures

Primary Outcome Measures

Changes in thyroid nodule size [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.

Secondary Outcome Measures

Treatment response that affect quality of life [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.
Sonographic features of nodules [Up to 12 months post-treatment]
Sonographic features will be summarized descriptively.
Cost of ultrasound-guided radiofrequency ablation (RFA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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