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Clinical Trial Summary

Thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for MNG. Monopolar radiofrequency ablation (RFA) is presently the best documented thermoablative technique. Although still RFA of thyroid nodules specifically, is still considered investigational in the United States, RFA of thyroid nodules has been used by several centers globally (mainly in South Korea, Italy, China, and Austria) since 2006[3] with excellent clinical outcomes. 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). In response to its increasing popularity, the Korean Society of Thyroid Radiology commissioned a Task Force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012[4], and these recommendations were recently revised in 2017[5] and the American Association of Clinical Endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules[6].


Clinical Trial Description

Patients with benign multinodular goiter who present to the New York Thyroid Center meeting the inclusion criteria will be eligible for enrollment. If clinically indicated, and after thorough evaluation of each individual case, patients will undergo either the RFA procedure, surgical procedure or observation, this will happen regardless of study participation. Once patients are evaluated and the best treatment option and/or course of action is determined, and explained to the patients in detail, then the patient will be offered to participate in the study. Study participation will consist of accessing information originated before and after any chosen treatment modality or course of action. Patients will also be asked to complete QoL surveys, as well as repeat thyroid ultrasound at 6 months (only for patients determined that observation is the best course of action for them clinically). Patients in observation usually get a repeated thyroid ultrasound at 1 year or sooner as standard of care. All patients will be required to fill out surveys upon entry into the study, 3, 6, and 12 months. We will use Telehealth in the case of patients that cannot come physically to a clinic visit. If this option is used for consultation, study participation will be offered and explained to patients this way, and if patients agree to research participation, the research team will send patients a RedCAP Link for E-Consenting, and subsequent completion of QoL surveys. All patients will be required to fill out surveys upon entry into the study, 3, 6, and 12 months. Patients will be offered to complete the surveys either online, over the phone or during their clinic visit. A RedCAP link will be sent to patients' emails if they decide that completing the surveys online is a good option for them. If patients prefer to complete the questionnaires over the phone at a later time, then research staff and patient will schedule the best time for the patient to be contacted for this purpose. For patients that come to the Endocrine Center and decide to proceed with the RFA procedure after their visit, or in the case that the research team cannot approach a patient for any given reason (e.g. not a good time for the patient or Telehealth is not an option), an Information Sheet (see document attached) will be used instead of written consent when necessary. In this case, study participation will be explained to the patient in detail over the phone using the Information Sheet. Patients will have ample time to ask questions and get answers. If patients decide to participate in the study, a copy of this form will be mailed to patients for their records. The recruiter will then proceed to schedule a convenient time for the patient to complete the quality of life questionnaires over the phone or using a RedCAP link, at a time that is convenient for the patient. The research team prefers to do this instead of submitting a request to the IRB for consenting the patient the same day of the procedure as the patient might be anxious or vulnerable at the time of the procedure. Surveys will be completed upon study entry and during clinical follow up visits. A waiver of written consent is requested for all subjects that have already been consented until this submission. These patients already have had either the RFA or surgical procedure, or observation. Only information already on file is required and no additional blood work, radiological procedures, or invasive or non- invasive studies are necessary for participation, there is no more than minimal risk to these subjects, and inclusion in the study will not adversely affect the rights and welfare of these subjects. Benign multinodular goiter (MNG) refers to an enlarged thyroid gland with nodules within it, frequently owing to iodine deficiency. It is the most common endocrine disorder worldwide[1]. Significant growths of nodules can cause symptomatic compressive symptoms such as dysphagia, dyspnea, or vascular compression of the neck vessels. On occasion, these nodules can develop autonomy and secrete excess thyroid hormone (toxic multinodular goiter). Surgical resection has been the preferred treatment option for symptomatic multinodular goiters and addresses both compressive symptoms as well as hyperthyroidism, but is associated with small, but not negligible risk of nerve injury, hypoparathyroidism, and may confer a risk of hypothyroidism and dependence on thyroid hormone supplementation[2]. Thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for MNG. Monopolar radiofrequency ablation (RFA) is presently the best documented thermoablative technique. Although RFA of thyroid nodules specifically, is still considered investigational in the United States, RFA of thyroid nodules has been used by several centers globally (mainly in South Korea, Italy, China, and Austria) since 2006[3] with excellent clinical outcomes. 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). In response to its increasing popularity, the Korean Society of Thyroid Radiology commissioned a Task Force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012[4], and these recommendations were recently revised in 2017[5] and the American Association of Clinical Endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules[6]. References:1. Durante C, Costante G, Lucisano G et al. The natural history of benign thyroid nodules. JAMA 313(9), 926-935 (2015). 2. De Rienzo-Madero B, Sabra JP, Gand E, Donatini G, Kraimps JL. Unilateral benign multinodular versus solitary goiter: Long-term contralateral reoperation rates after lobectomy . Surgery doi:10.1016/j.surg.2018.04.074 (2018). 3. Kim YS, Rhim H, Tae K, Park DW, Kim ST. Radiofrequency ablation of benign cold thyroid nodules: initial clinical experience. Thyroid 16(4), 361-367 (2006). 4. Na DG, Lee JH, Jung SL et al. Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean J Radiol 13(2), 117-125 (2012). 5. Kim JH, Baek JH, Lim HK et al. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol 19(4), 632-655 (2018). 6. Gharib H, Papini E, Garber JR et al. American Association of Clinical Endocrinologists, American College of Endocrinology, and Associazione Medici Endocrinologi Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules-- 2016 Update. Endocr Pract 22(5), 622-639 (2016). 7. Jeong WK, Baek JH, Rhim H et al. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol 18(6), 1244-1250 (2008). 8. Baek JH, Kim YS, Lee D, Huh JY, Lee JH. Benign predominantly solid thyroid nodules: prospective study of efficacy of sonographically guided radiofrequency ablation versus control condition. AJR Am J Roentgenol 194(4), 1137-1142 (2010). 9. Watt T, Barbesino G, Bjorner JB et al. Cross-cultural validity of the thyroid-specific qualityof-life patient-reported outcome measure, ThyPRO. Qual Life Res 24(3), 769-780 (2015). 10. Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid 28(4), 472-480 (2018). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05189314
Study type Observational
Source Columbia University
Contact Jennifer H Kuo, MD MS
Phone 212-305-6969
Email [email protected]
Status Recruiting
Phase
Start date August 30, 2019
Completion date August 30, 2024

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