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

NCT05003856 | Terminated

• 2 other identifiers: 2021-0542NCI-2021-08354
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Gland Neoplasm; Recurrent Thyroid Gland Carcinoma; Thyroid Gland Follicular Tumor of Uncertain Malignant Potential; Thyroid Gland Nodule; Thyroid Gland Papillary Carcinoma

Outcome Measures

Primary Outcomes (1)

• Changes in thyroid nodule size

  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 Outcomes (3)

• Treatment response that affect quality of life

  Up to 12 months post-treatment

• Sonographic features of nodules

  Up to 12 months post-treatment

• Cost of ultrasound-guided radiofrequency ablation (RFA)

  Up to 12 months post-treatment

Study Arms (1)

Treatment (RFA)

EXPERIMENTAL

Patients undergo ultrasound guided RFA over 1-2 hours.

Other: Quality-of-Life Assessment; Procedure: Radiofrequency Ablation

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (RFA)

Radiofrequency Ablation PROCEDURE

Undergo RFA

Also known as: Ablation, Radiofrequency, Radiofrequency Interstitial Ablation, RFA

Treatment (RFA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule; Thyroid Cancer, Papillary

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kim O Learned

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 12, 2021
• Study Start: August 29, 2022
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

US (1)