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.
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.
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.
Single group
Radiofrequency Ablation of Papillary Thyroid Cancer
Procedure/SurgeryRadiofrequency 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
VIVA combo RF Generator with Coagulation Electrode
DeviceEvaluating 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
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).
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.
Ultrasound characteristics following RFA
including features used to differentiate successfully treated tumors from residual or recurrent disease
Tumor volume change over time,
measured by volume reduction ratio (VRR)
Complication rate of radiofrequency ablation, including but not limited to:
Voice changes, Hematoma, Pain, and Skin burns
Patient-reported outcome (Patient Satisfaction)
Patient satisfaction will be assessed using a study-specific questionnaire evaluating satisfaction with the procedure and overall care. Scores range from 1 to 5, with higher scores indicating greater satisfaction (better outcome) and lower scores indicating lower satisfaction.
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