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NCT07376837

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

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-05

Completion Date

2027-07-01

Last Updated

2026-01-29

Healthy Volunteers

Conditions

Thyroid Papillary Carcinoma

Interventions

PROCEDURE

Radiofrequency Ablation of Papillary Thyroid Cancer

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

DEVICE

VIVA combo RF Generator with Coagulation Electrode

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

Inclusion criteria: * 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. Exclusion Criteria: * 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