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

M.D. Anderson Cancer Center

Status

Terminated

Conditions

Benign Thyroid Gland Neoplasm

Thyroid Gland Papillary Carcinoma

Thyroid Gland Nodule

Recurrent Thyroid Gland Carcinoma

Thyroid Gland Follicular Tumor of Uncertain Malignant Potential

Treatments

Other: Quality-of-Life Assessment

Procedure: Radiofrequency Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT05003856

2021-0542 (Other Identifier)

NCI-2021-08354 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No 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