Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study

NCT07376837 | Not Yet Recruiting DMC

• 1 other identifier: 25-5017
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot, single-arm clinical study evaluates the feasibility, safety, and effectiveness of radiofrequency ablation (RFA) as a curative treatment for small, low-risk papillary thyroid cancer (PTC). The study will enroll 30 adult patients (≥18 years) with biopsy-confirmed PTC measuring \<2 cm, who decline surgery or active surveillance, or who are transitioning from active surveillance to active treatment. Eligible participants will undergo ultrasound-guided RFA performed with curative intent at University Health Network. Patients will be followed for up to 12 months with scheduled clinical visits, neck ultrasounds, blood tests, voice assessments, and patient-reported outcome questionnaires. A biopsy of the ablation site at 6-12 months will be used to assess local cancer control. The primary objective is to determine the local cure rate and safety profile of RFA for low-risk PTC. Secondary objectives include evaluating post-ablation ultrasound features, patient-reported quality of life, and the feasibility of implementing a multidisciplinary thyroid RFA program within routine clinical practice. Results from this study will provide important preliminary data to inform future larger trials comparing RFA with surgery and active surveillance for selected patients with low-risk papillary thyroid cancer.

Conditions

Thyroid Papillary Carcinoma

Keywords

Thyroid Radiofrequency Ablation; Minimally Invasive Treatment; Thyroid Papillary Carcinoma; Ultrasound-guided; Low-risk cancer-focused; Thyroid-sparing

Outcome Measures

Primary Outcomes (2)

• Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency

  Local cure rate of papillary thyroid cancer (PTC) following radiofrequency ablation, assessed by ultrasound-guided fine needle aspiration or core biopsy of the ablation site at 6-12 months, with local cure defined as no evidence of malignancy on biopsy (when diagnostic material is obtained).

  From enrollment to the end of treatment at 12 months.

• Safety of the RFA procedure

  Safety of the RFA procedure, measured by the incidence and nature of procedure-related complications, including but not limited to voice changes, hematoma, pain, skin burns, and other adverse events.

  From enrollment to the end of treatment at 12 months.

Secondary Outcomes (9)

• Ultrasound characteristics following RFA

  From enrollment to the end of treatment at 12 months

• Tumor volume change over time,

  at 6 and 12 months post-RFA

• Complication rate of radiofrequency ablation, including but not limited to:

  From Treatment to the end of study at 12 months

• Patient-reported outcome (Patient Satisfaction)

  From enrollment to the end of study at 12 months.

• Patient-reported outcome Voice Handicap Index-10 (VHI-10)

  Time Frame: From enrollment to the end of study at 12 months.

Study Arms (1)

Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer

EXPERIMENTAL

This single study arm includes adult participants with biopsy-confirmed, low-risk papillary thyroid cancer (\<2 cm) who undergo curative-intent radiofrequency ablation (RFA) of the thyroid tumor. RFA is performed once, on an outpatient basis, using a percutaneous, ultrasound-guided approach with an internally cooled radiofrequency electrode. The procedure is carried out under local anesthesia with conscious sedation, using a standardized moving-shot technique, with hydrodissection as needed to protect adjacent structures. No study drugs are administered as part of this intervention. The RFA procedure is a one-time treatment, although repeat ablation may be considered if residual disease is identified during follow-up, based on clinical judgment and participant consent. All participants in this arm follow the same post-procedure monitoring and follow-up schedule, which includes clinical assessments, neck ultrasound, thyroid blood tests, voice evaluation, patient-reported outcome quest

Procedure: Radiofrequency Ablation of Papillary Thyroid Cancer; Device: VIVA combo RF Generator with Coagulation Electrode

Interventions

Radiofrequency Ablation of Papillary Thyroid Cancer PROCEDURE

Radiofrequency ablation (RFA) is a minimally invasive, image-guided procedure used to destroy targeted thyroid cancer tissue using controlled heat. In this study, RFA is performed percutaneously under real-time ultrasound guidance using an internally cooled radiofrequency electrode inserted into the thyroid tumor through the skin. The procedure is carried out under local anesthesia with conscious sedation. A standardized moving-shot technique is used to ablate the entire tumor, and hydrodissection may be applied to protect nearby critical structures such as the vocal cord nerve, trachea, and esophagus. RFA is delivered as a single-session treatment with curative intent and is performed on an outpatient basis, with most patients returning home the same day. This intervention preserves the thyroid gland and avoids surgical incisions. Treatment response is assessed through follow-up imaging, clinical evaluations, patient-reported outcomes, and an ultrasound-guided biopsy of the treated

Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer

VIVA combo RF Generator with Coagulation Electrode DEVICE

Evaluating the Feasibility, Safety and Efficacy of Radiofrequency Ablation (RFA) for Curative Treatment of Small Low-Risk Thyroid Papillary Cancer: A Pilot Single Arm Clinical Trial - VIVA combo RF Generator with Coagulation Electrode

Also known as: Southmedic Inc,

Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed papillary thyroid carcinoma (PTC) by fine-needle aspiration (FNA -Bethesda V/VI ) or core needle biopsy.
• Single or multiple lesions, each 2.0 cm in maximum diameter.
• Intrathyroidal tumors (i.e., no extrathyroidal extension, no clinical/radiological evidence of nodal metastases, nor distant metastases).
• Lesions located at a safe distance (\>2 mm) from critical structures (e.g., trachea, esophagus, carotid artery) or accessible with hydrodissection.
• ≤T1b (i.e. \< 2cm maximal diameter), N0 or Nx, M0 (no clinical or radiological evidence of lymph node or distant metastasis).
• Patients unfit for surgery due to comorbidities or who refuse surgery.
• ≥18 years old
• Not pregnant at the time of RFA.
• Able to understand and voluntarily sign informed consent.

You may not qualify if:

• Evidence of lymph node involvement (clinically or radiologically suspicious or confirmed metastatic nodes) or distant metastasis (e.g., lung, bone).
• Tumors with extrathyroidal extension
• Tumors with extensive calcification
• Tumors located within 2 mm of critical structures where RFA would pose an unacceptably high risk and where hydrodissection is not feasible.
• Previous thyroid surgery or ablation (RFA, ethanol, laser, or microwave) at the index tumor site.
• Known diagnosis of anaplastic, poorly differentiated, or other aggressive thyroid cancer variants.
• Pregnant or breastfeeding at the time of enrollment.
• Bleeding diathesis or use of anticoagulants that cannot be discontinued safely prior to RFA.
• Severe comorbid illness that limits life expectancy to less than 5 years.
• Inability to adhere to study follow-up schedule or procedures or lacking decision-making capacity.
• Implanted electrical devices such as pacemakers or neurostimulators
• Infection in the neck including skin infection or thyroiditis at time of planned ablation.
• Severe cervical anatomy distortion (prior neck surgery or radiation with distorted anatomy that prevents safe RFA

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (27)

• Sakai T, Sugitani I, Ebina A, Fukuoka O, Toda K, Mitani H, Yamada K. Active Surveillance for T1bN0M0 Papillary Thyroid Carcinoma. Thyroid. 2019 Jan;29(1):59-63. doi: 10.1089/thy.2018.0462. Epub 2019 Jan 8.

  PMID: 30560718 RESULT

• Dionisio T, Mauri G. Ultrasound Evaluation of Ablated Thyroid Nodules: An Emerging Problem. Thyroid. 2024 Aug;34(8):1062-1063. doi: 10.1089/thy.2024.0244. Epub 2024 Jul 4. No abstract available.

  PMID: 38916184 RESULT

• Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. doi: 10.1186/1477-7525-5-15.

  PMID: 17352831 RESULT

• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

  PMID: 12926578 RESULT

• Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.

  PMID: 24698296 RESULT

• Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.

  PMID: 15475780 RESULT

• Bresner L, Banach R, Rodin G, Thabane L, Ezzat S, Sawka AM. Cancer-related worry in Canadian thyroid cancer survivors. J Clin Endocrinol Metab. 2015 Mar;100(3):977-85. doi: 10.1210/jc.2014-3169. Epub 2014 Nov 13.

  PMID: 25393643 RESULT

• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

  PMID: 8433390 RESULT

• Singer S, Jordan S, Locati LD, Pinto M, Tomaszewska IM, Araujo C, Hammerlid E, Vidhubala E, Husson O, Kiyota N, Brannan C, Salem D, Gamper EM, Arraras JI, Ioannidis G, Andry G, Inhestern J, Gregoire V, Licitra L; EORTC Quality of Life Group, the EORTC Head and Neck Cancer Group, and the EORTC Endocrine Task Force. The EORTC module for quality of life in patients with thyroid cancer: phase III. Endocr Relat Cancer. 2017 Apr;24(4):197-207. doi: 10.1530/ERC-16-0530. Epub 2017 Feb 21.

  PMID: 28223365 RESULT

• Kim C, Lee JH, Choi YJ, Kim WB, Sung TY, Baek JH. Complications encountered in ultrasonography-guided radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers. Eur Radiol. 2017 Aug;27(8):3128-3137. doi: 10.1007/s00330-016-4690-y. Epub 2016 Dec 14.

  PMID: 27975148 RESULT

• Baek JH, Lee JH, Sung JY, Bae JI, Kim KT, Sim J, Baek SM, Kim YS, Shin JH, Park JS, Kim DW, Kim JH, Kim EK, Jung SL, Na DG; Korean Society of Thyroid Radiology. Complications encountered in the treatment of benign thyroid nodules with US-guided radiofrequency ablation: a multicenter study. Radiology. 2012 Jan;262(1):335-42. doi: 10.1148/radiol.11110416. Epub 2011 Oct 13.

  PMID: 21998044 RESULT

• Li X, Li Y, Yan L, Xiao J, Yang Z, Jing H, Zhang M, Luo Y. Sonographic Evolution and Pathologic Findings of Papillary Thyroid Cancer After Radiofrequency Ablation: A Five-Year Retrospective Cohort Study. Thyroid. 2024 Jan;34(1):54-63. doi: 10.1089/thy.2023.0415. Epub 2023 Nov 20.

  PMID: 37885207 RESULT

• Rachmasari KN, Schmitz JJ, Castro MR, Kurup AN, Lee RA, Stan MN. Exploring Radiofrequency Ablation for T1 Papillary Thyroid Cancer in the United States: Mayo Clinic Experience. Mayo Clin Proc. 2024 Nov;99(11):1702-1709. doi: 10.1016/j.mayocp.2024.04.010. Epub 2024 Aug 2.

  PMID: 39093272 RESULT

• Li X, Yan L, Xiao J, Li Y, Yang Z, Zhang M, Luo Y. Long-Term Outcomes and Risk Factors of Radiofrequency Ablation for T1N0M0 Papillary Thyroid Carcinoma. JAMA Surg. 2024 Jan 1;159(1):51-58. doi: 10.1001/jamasurg.2023.5202.

  PMID: 37878294 RESULT

• Zhang M, Luo Y, Zhang Y, Tang J. Efficacy and Safety of Ultrasound-Guided Radiofrequency Ablation for Treating Low-Risk Papillary Thyroid Microcarcinoma: A Prospective Study. Thyroid. 2016 Nov;26(11):1581-1587. doi: 10.1089/thy.2015.0471. Epub 2016 Aug 18.

  PMID: 27445090 RESULT

• Cho SJ, Baek SM, Na DG, Lee KD, Shong YK, Baek JH. Five-year follow-up results of thermal ablation for low-risk papillary thyroid microcarcinomas: systematic review and meta-analysis. Eur Radiol. 2021 Sep;31(9):6446-6456. doi: 10.1007/s00330-021-07808-x. Epub 2021 Mar 13.

  PMID: 33713168 RESULT

• Cho SJ, Suh CH, Baek JH, Chung SR, Choi YJ, Chung KW, Shong YK, Lee JH. Active Surveillance for Small Papillary Thyroid Cancer: A Systematic Review and Meta-Analysis. Thyroid. 2019 Oct;29(10):1399-1408. doi: 10.1089/thy.2019.0159. Epub 2019 Sep 27.

  PMID: 31368412 RESULT

• Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.

  PMID: 32126932 RESULT

• Goldstein DP, Ghai S, Corsten M, Bissada E, Audet N, Zhang H, Nichols A, Morrison D, Johnson-Obeski S, Anderson DW, Prisman E, Baxter NN, Jones J, Gafni A, Witterick I, Sawka AM. Proceedings of the Canadian Thyroid Cancer Active Surveillance Study Group 2019 national investigator meeting. J Otolaryngol Head Neck Surg. 2021 Jun 25;50(1):40. doi: 10.1186/s40463-021-00514-0.

  PMID: 34172096 RESULT

• Sawka AM, Ghai S, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP, On Behalf Of The Canadian Thyroid Cancer Active Surveillance Study Group. Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic. Cancers (Basel). 2021 Jan 20;13(3):371. doi: 10.3390/cancers13030371.

  PMID: 33498497 RESULT

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Gooden E, Brown DH, Eskander A, Zahedi A, Chung J, Su J, Xu W, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Active Surveillance Study Group (Greater Toronto Area). A Quantitative Analysis Examining Patients' Choice of Active Surveillance or Surgery for Managing Low-Risk Papillary Thyroid Cancer. Thyroid. 2022 Mar;32(3):255-262. doi: 10.1089/thy.2021.0485. Epub 2022 Feb 17.

  PMID: 35019770 RESULT

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Zahedi A, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP. Decision Regret Following the Choice of Surgery or Active Surveillance for Small, Low-Risk Papillary Thyroid Cancer: A Prospective Cohort Study. Thyroid. 2024 May;34(5):626-634. doi: 10.1089/thy.2023.0634. Epub 2024 Apr 8.

  PMID: 38481111 RESULT

• Ghai S, Goldstein DP, Sawka AM. Ultrasound Imaging in Active Surveillance of Small, Low-Risk Papillary Thyroid Cancer. Korean J Radiol. 2024 Aug;25(8):749-755. doi: 10.3348/kjr.2024.0148. Epub 2024 Jul 15.

  PMID: 39028013 RESULT

• Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Zahedi A, Gooden E, Eskander A, Chung J, Devon K, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Gender Differences in Fears Related to Low-Risk Papillary Thyroid Cancer and Its Treatment. JAMA Otolaryngol Head Neck Surg. 2023 Sep 1;149(9):803-810. doi: 10.1001/jamaoto.2023.1642.

  PMID: 37410454 RESULT

• Ghai S, O'Brien C, Goldstein DP, Sawka AM; Canadian Thyroid Cancer Active Surveillance Study Group. Ultrasound in active surveillance for low-risk papillary thyroid cancer: imaging considerations in case selection and disease surveillance. Insights Imaging. 2021 Sep 16;12(1):130. doi: 10.1186/s13244-021-01072-9.

  PMID: 34529219 RESULT

• Sawka AM, Ghai S, Tomlinson G, Baxter NN, Corsten M, Imran SA, Bissada E, Lebouef R, Audet N, Brassard M, Zhang H, Gupta M, Nichols AC, Morrison D, Johnson-Obeski S, Prisman E, Anderson D, Chandarana SP, Ghaznavi S, Jones J, Gafni A, Matelski JJ, Xu W, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group. A Protocol for a Pan-Canadian Prospective Observational Study on Active Surveillance or Surgery for Very Low Risk Papillary Thyroid Cancer. Front Endocrinol (Lausanne). 2021 Jun 10;12:686996. doi: 10.3389/fendo.2021.686996. eCollection 2021.

  PMID: 34194396 RESULT

• Sawka AM, Ghai S, Tomlinson G, Rotstein L, Gilbert R, Gullane P, Pasternak J, Brown D, de Almeida J, Irish J, Chepeha D, Higgins K, Monteiro E, Jones JM, Gafni A, Goldstein DP. A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer. BMJ Open. 2018 Apr 12;8(4):e020298. doi: 10.1136/bmjopen-2017-020298.

  PMID: 29654030 RESULT

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

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

Study Officials

• Sangeet Ghai, MD

  University Health Network - Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateri Corr

CONTACT

416-500-5737; kateri.corr@uhn.ca

Sangeet Ghai, Division Head, Abdominal Imagig, Dept of Medical Imaging, MD

CONTACT

416-340-4656; sangeet.ghai@uhn.ca

Study Design

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

Model Details: This is a single-center, prospective, single-arm interventional pilot study designed to evaluate radiofrequency ablation (RFA) as a curative-intent treatment for small, low-risk papillary thyroid cancer. All enrolled participants receive the same intervention (RFA), with no randomization or comparison group, as the primary purpose is to assess feasibility, safety, and preliminary effectiveness rather than comparative efficacy. Participants undergo a one-time ultrasound-guided RFA procedure, followed by a structured follow-up schedule over 12 months that includes clinical assessments, imaging, laboratory testing, voice evaluations, patient-reported outcome measures, and a biopsy of the treated site at 6-12 months to assess local cancer control. Outcomes are collected prospectively using standardized protocols. As a pilot study, this model is intended to generate high-quality preliminary data to inform the design of future larger, potentially randomized studies comparing RFA with stand

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 29, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified IPD and supporting documents will be made available after publication of the primary study results or within 12 months of study completion, whichever occurs first.
• Access Criteria: IPD will be shared upon reasonable request with qualified researchers. Requests must include a brief research proposal and intended use of the data. All requests will be reviewed and approved by the Principal Investigator and must comply with Research Ethics Board (REB) approval, participant consent, and institutional data-sharing policies. Conditions of use: Data will be provided in a de-identified format and shared under a formal data-sharing