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Clinical Trial Summary

Differentiated thyroid cancer (DTC), which includes papillary and follicular cancer, comprises the vast majority (>90%) of all thyroid cancers. The yearly incidence has nearly tripled from 4.9 per 100,000 in 1975 to 14.3 per 100,000 in 2009. Almost the entire change has been attributed to an increase in the incidence of papillary thyroid cancer (PTC). This increase in incidence is likely driven by the diagnosis of small PTCs <1cm in size due to the increasing use of neck ultrasonography. In 2009, Miyauchi et al published their landmark study observing 1235 patients with small papillary thyroid cancer over 22 years. They noted that at 10 years follow-up, only 8% had tumor enlargement of >3mm and 3.8% had novel lymph node metastases proving that the majority of these 'microcarcinomas' were low-risk and indolent in nature. In 2017, the US commissioned task force evaluating the risks and benefits of treatment of these small cancers concluded that surgical treatment of these microcarcinomas was associated with a low, but not negligible, risk of surgical complications: 2.12-5.93% risk of permanent hypoparathyroidism and 0.99-2.13% risk of permanent recurrent laryngeal nerve injury. In addition, 98.8% of patients treated with thyroidectomy received radioactive iodine that was associated with an excess absolute risk of 11.9 to 13.3 cancers per 10, 000 person-years for second malignancies. In accordance with these data, the most recent societal guidelines for management of thyroid nodules and differentiated thyroid cancer have favored less aggressive management of microcarcinomas, with active surveillance as a reasonable option for management. However, although this may appeal to a subset of individuals who are especially risk and surgery averse, many patients are still uncomfortable with observing 'cancer' and still opt for the least invasive approach to surgical treatment. Thyroid surgery has always been the mainstay of treatment for thyroid cancer. Although associated with excellent outcomes in experienced hands, thyroid surgery carries a low risk of complications that include recurrent or superior laryngeal nerve injury leading to voice changes, hypoparathyroidism, hypothyroidism with need for thyroid hormone supplementation, and unsightly scarring. Although many patients with thyroid cancer find these risks acceptable, these risks are sometimes less acceptable to patients with benign disease. In an era when the medical field is treating thyroid diseases less aggressively, there is a pressing need to identify approaches to treat indolent malignant disease less invasively. Introduced in the early 2000s, ultrasound-guided percutaneous ablation of thyroid lesions has emerged as a potential alternative to surgery in patients with benign thyroid nodules. Of the myriad ablation methods, the most commonly used technique is radiofrequency ablation (RFA). An expanding body of evidence shows that radiofrequency ablation and other percutaneous interventions are effective treatments for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-70% with durable resolution of compressive and hyperthyroid symptoms. In addition, RFA has been used as an effective alternative treatment in the management of locally recurrent thyroid cancers in patients who are not good surgical candidates. In addition, RFA of other solid tumors is a commonly performed procedure in the United states and all RFA devices, including the device that we will use for the clinical care of these patients, are cleared by the FDA (New devices/technology to the market are approved, but devices that have a predicate device/technology that are already on the market only need to be cleared). Recently, a systematic review and meta-analysis of thermal ablation techniques for micropapillary carcinomas found that among 503 low risk PTCs in 470 patients, no patient experienced tumor recurrence or distant metastasis, 2 patients (0.4%) experienced lymph node metastasis, 1 patient (0.2%) developed a new PTMC, which was successfully treated by additional ablation, and 5 patients (1.1%) underwent delayed surgery after ablation, including the two patients with lymph node metastasis and three additional patients with unknown etiology. Although these percutaneous techniques have been steadily gaining acceptance in Europe and Asia over the past 20 years, they have been slow to be adopted in the US. In 2018 Hamidi et al published the first US institutional experience of 14 patients who received RFA, reigniting interest in the procedure, however, there remains a dearth of data regarding clinical experience in the United States and no randomized clinical trials have been performed evaluating RFA vs active surveillance for micropapillary carcinomas.


Clinical Trial Description

Prospective Data Collection This is a single-arm, prospective cohort study of patients with papillary thyroid microcarcinoma who undergo treatment with US-guided radiofrequency ablation (RFA). Adult patients >/= 18 years of age who have a thyroid nodule </= 1.5cm in size with aspiration biopsy demonstrating suspicious for malignancy or malignancy (Bethesda V or VI) cytology will be eligible for enrollment in the study. If clinically indicated and after thorough evaluation of each individual case, participants will be offered ultrasound guided RFA in addition to active surveillance and surgery as viable options for management and will be included in the study if they opt for RFA. Once patients are evaluated and the best treatment option and/or course of action is determined, and explained to the patients in detail, if the patient opt for RFA then the patient will be offered to participate in the study. Interventions: 1) RFA: ultrasound-guided thermoablation will be performed using STARmed internally cooled RFA electrodes (18 gauge) powered by the VIVA RF generator in accordance with the 'moving shot' technique described by Baek et al.[7, 8]. The RFA procedure uses image guidance to place an electrode through the skin into the target area. In RFA, high frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion. 2) Follow-up ultrasounds will be performed at 1-, 3-, 6-, 12-, and 24- months post procedure. The above-mentioned interventions are conducted per standard of care and not for research purposes. Since this is a single-arm cohort study, a formal power analysis is not applicable. Variables: Primary outcome measure is volume reduction ratio (VRR) of the nodule. RFA of IRB-AAAT6770 Page 4 of 31 ( Y1M0 ) Annual/Progress Report due: 10/13/2022 Is the purpose of this submission to obtain an exemption determination, in accordance with 45CFR46.101(b): No Is the purpose of this submission to seek expedited review , as per the federal categories referenced in 45CFR46.110? No Is there any external funding or support that is applied for or awarded, or are you the recipient of a gift, for this project? Yes microcarcinomas can decrease nodule volume up to 95-99% from baseline at 24 months. Secondary outcome measures include nodule recurrence, regrowth, cosmetic and symptom scores. We will describe and compare the baseline characteristics of subjects including age, sex, race, tumor size, tumor sonographic appearance including echogenicity, vascularity, presence of calcifications, and solidity, and relevant serum studies. Analysis: Continuous variable distributions will be assessed by means of histograms and tests for non-normality and skewness; the log transform will be applied where appropriate. Univariable analyses will be performed using the 2, student's t-test, and Mann-Whitney test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05189821
Study type Observational
Source Columbia University
Contact Jennifer H Kuo, MD MS
Phone 212-305-6969
Email [email protected]
Status Recruiting
Phase
Start date November 1, 2021
Completion date November 30, 2026

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