RFA Treatment for Papillary Thyroid Microcarcinoma

NCT ID: NCT05189821

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2027-11-30

Brief Summary

Thyroid surgery has always been the mainstay of treatment for thyroid cancer. 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.

The purpose of this observational study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of Papillary Thyroid Microcarcinoma (PTMC) in patients that have already agreed to RFA procedure based on treating physician recommendation. This is a data collection study in which we ask participants to give us access to information generated before and after RFA treatment of their condition. The RFA procedure uses image guidance to place an electrode through the skin into the target tumor. In RFA, high-frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.

Detailed Description

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 a study observing 1235 patients with small papillary thyroid cancer over 22 years, it was 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 the investigators 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. 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.

Conditions

Papillary Thyroid Microcarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Radiofrequency Ablation

Ultrasound guided radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients (>/= 18 years)
• Biopsy proven papillary thyroid microcarcinoma (>/= 1.5cm in greatest diameter, PTMC)
• Either refuse surgery or are not good surgical candidates

Exclusion Criteria

• Cardiac arrhythmia
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Kuo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer H Kuo, MD MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer H Kuo, MD MS

Role: CONTACT

jhk2029@cumc.columbia.edu

212-305-6969

Vilma Rosario

Role: CONTACT

vr2222@cumc.columbia.edu

Facility Contacts

Jennifer H Kuo, MD MS

Role: primary

jhk2029@cumc.columbia.edu

212-305-6969

References

Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956.

Reference Type: BACKGROUND

PMID: 25734734 (View on PubMed)

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. 2019 Jan;165(1):75-79. doi: 10.1016/j.surg.2018.04.074. Epub 2018 Nov 8.

Reference Type: BACKGROUND

PMID: 30415868 (View on PubMed)

Kim YS, Rhim H, Tae K, Park DW, Kim ST. Radiofrequency ablation of benign cold thyroid nodules: initial clinical experience. Thyroid. 2006 Apr;16(4):361-7. doi: 10.1089/thy.2006.16.361.

Reference Type: BACKGROUND

PMID: 16646682 (View on PubMed)

Na DG, Lee JH, Jung SL, Kim JH, Sung JY, Shin JH, Kim EK, Lee JH, Kim DW, Park JS, Kim KS, Baek SM, Lee Y, Chong S, Sim JS, Huh JY, Bae JI, Kim KT, Han SY, Bae MY, Kim YS, Baek JH; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean J Radiol. 2012 Mar-Apr;13(2):117-25. doi: 10.3348/kjr.2012.13.2.117. Epub 2012 Mar 7.

Reference Type: BACKGROUND

PMID: 22438678 (View on PubMed)

Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14.

Reference Type: BACKGROUND

PMID: 29962870 (View on PubMed)

Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. 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. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.

Reference Type: BACKGROUND

PMID: 27167915 (View on PubMed)

Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, Lee D. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol. 2008 Jun;18(6):1244-50. doi: 10.1007/s00330-008-0880-6. Epub 2008 Feb 20.

Reference Type: BACKGROUND

PMID: 18286289 (View on PubMed)

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. 2010 Apr;194(4):1137-42. doi: 10.2214/AJR.09.3372.

Reference Type: BACKGROUND

PMID: 20308523 (View on PubMed)

Watt T, Barbesino G, Bjorner JB, Bonnema SJ, Bukvic B, Drummond R, Groenvold M, Hegedus L, Kantzer V, Lasch KE, Marcocci C, Mishra A, Netea-Maier R, Ekker M, Paunovic I, Quinn TJ, Rasmussen AK, Russell A, Sabaretnam M, Smit J, Torring O, Zivaljevic V, Feldt-Rasmussen U. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO. Qual Life Res. 2015 Mar;24(3):769-80. doi: 10.1007/s11136-014-0798-1. Epub 2014 Sep 7.

Reference Type: BACKGROUND

PMID: 25194574 (View on PubMed)

Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20.

Reference Type: BACKGROUND

PMID: 29490593 (View on PubMed)

Other Identifiers

AAAT6770

Identifier Type: -

Identifier Source: org_study_id