Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study
PTC-RFA
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedStudy Start
First participant enrolled
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
May 19, 2026
May 1, 2026
11 months
January 15, 2026
May 14, 2026
Conditions
Keywords
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.
- +4 more secondary outcomes
Study Arms (1)
Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer
EXPERIMENTALThis 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
Interventions
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
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sangeet Ghai, MD
University Health Network - Toronto General Hospital
Central Study Contacts
Sangeet Ghai, Division Head, Abdominal Imaging-Dept of Medical Imaging, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
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
May 19, 2026
Record last verified: 2026-05
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
De-identified individual participant data (IPD) from this study may be shared with qualified researchers upon reasonable request. Data sharing will be considered after completion of the primary analyses and publication of the main study results. Shared data will exclude all direct identifiers and will comply with institutional policies, REB requirements, and applicable privacy legislation. Requests will be reviewed by the study Principal Investigator to ensure scientific validity, ethical appropriateness, and alignment with the original consent. Data will be shared under a data-sharing agreement outlining the permitted use of the data, data security requirements, and restrictions on re-identification or further sharing.