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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
Ancillary studies
Undergo RFA
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: Baseline up to 12 months
Treatment response that affect quality of life
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.
Time frame: Up to 12 months post-treatment
Sonographic features of nodules
Sonographic features will be summarized descriptively.
Time frame: Up to 12 months post-treatment
Cost of ultrasound-guided radiofrequency ablation (RFA)
The cost of ultrasound-guided RFA will be summarized. Comparisons may be made with historical data on the costs associated with surgical thyroidectomy.
Time frame: Up to 12 months post-treatment
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