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

May 14, 2026 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a pilot clinical trial designed to evaluate a less invasive treatment option for adults with small, low-risk papillary thyroid cancer (PTC). PTC is the most common type of thyroid cancer and is often slow growing with an excellent prognosis. Standard treatment usually involves surgery to remove part or all of the thyroid gland. While surgery is highly effective, it may be associated with complications such as voice changes, low calcium levels, prolonged recovery, and the need for lifelong thyroid hormone replacement. For some patients, close monitoring without treatment (active surveillance) is an option, but this approach can cause ongoing anxiety and uncertainty.

Radiofrequency ablation (RFA) is a minimally invasive, image-guided procedure that uses controlled heat to destroy targeted tissue. RFA has been widely used to treat benign thyroid nodules and is increasingly being explored as a treatment for carefully selected small thyroid cancers. This study aims to determine whether RFA can safely and effectively eliminate small PTCs while preserving the thyroid gland and reducing the impact of treatment on patients' daily lives.

The study will enroll 30 adult participants (18 years or older) with biopsy-confirmed papillary thyroid cancer measuring less than 2 cm, with no evidence of spread outside the thyroid or to lymph nodes. All participants will have previously been offered standard treatment options and have chosen not to undergo surgery or active surveillance, or will be transitioning from active surveillance to active treatment. Each potential participant will be reviewed by a multidisciplinary team that includes radiology, endocrinology, and surgical specialists to ensure the treatment is appropriate and safe.

The RFA procedure will be performed on an outpatient basis under local anesthesia and light sedation, using real-time ultrasound guidance to precisely target the cancer while protecting nearby structures such as the vocal cords, trachea, and esophagus. Patients are typically observed briefly after the procedure and can return home the same day.

Following treatment, participants will be followed closely for up to 12 months. Follow-up includes clinic visits, neck ultrasound examinations, blood tests to assess thyroid function, voice assessments, and questionnaires that evaluate symptoms, quality of life, satisfaction with treatment, and decision-related concerns. A key component of follow-up is an ultrasound-guided biopsy of the treated area performed 6 to 12 months after RFA, which will be used to determine whether the cancer has been successfully eradicated.

The primary focus of the study is to assess local cancer control and safety of RFA, including the frequency and severity of any complications. Additional goals include understanding how treated thyroid cancers appear on ultrasound over time, evaluating patient-reported outcomes, and assessing the practicality of delivering and sustaining a multidisciplinary thyroid RFA program within a Canadian academic health-care setting.

The results of this study will provide important early evidence on the role of radiofrequency ablation as a potential alternative to surgery for selected patients with low-risk papillary thyroid cancer and will help guide future larger clinical trials and treatment guidelines.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sangeet Ghai, Division Head, Abdominal Imaging-Dept of Medical Imaging, MD
  • Phone Number: 416-340-4656
  • Email: sangeet.ghai@uhn.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • University Health Network - Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Sangeet Ghai, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid Cancer

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

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
Other Names:
  • Southmedic Inc,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency
Time Frame: From enrollment to the end of treatment at 12 months.
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
Time Frame: From enrollment to the end of treatment at 12 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound characteristics following RFA
Time Frame: From enrollment to the end of treatment at 12 months
including features used to differentiate successfully treated tumors from residual or recurrent disease
From enrollment to the end of treatment at 12 months
Tumor volume change over time,
Time Frame: at 6 and 12 months post-RFA
measured by volume reduction ratio (VRR)
at 6 and 12 months post-RFA
Complication rate of radiofrequency ablation, including but not limited to:
Time Frame: From Treatment to the end of study at 12 months
Voice changes, Hematoma, Pain, and Skin burns
From Treatment to the end of study at 12 months
Patient-reported outcome (Patient Satisfaction)
Time Frame: From enrollment to the end of study at 12 months.
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.
From enrollment to the end of study at 12 months.
Patient-reported outcome Voice Handicap Index-10 (VHI-10)
Time Frame: Time Frame: From enrollment to the end of study at 12 months.
Self-reported Voice Handicap Index-10 (VHI-10): Total score range 0-40; higher scores indicate worse voice-related handicap.
Time Frame: From enrollment to the end of study at 12 months.
Patient-reported outcome (EORTC QLQ-C30)
Time Frame: From enrollment to the end of the study at 12 months
The EORTC QLQ-C30 is a validated cancer-specific questionnaire assessing global health status and multiple functional and symptom domains. Scores are transformed to a 0-100 scale. For functional and global health status scales, higher scores indicate better quality of life/functioning, whereas for symptom scales, higher scores indicate worse symptom burden.
From enrollment to the end of the study at 12 months
Patient Reported outcome - The Assessment of Survivor Concerns (ASC)
Time Frame: From enrollment to the end of study at 12 months
The Assessment of Survivor Concerns (ASC) is a validated patient-reported questionnaire designed to evaluate cancer survivors' concerns across multiple domains (e.g., physical, emotional, social, and existential concerns). Total scores range from 0 to 100, with higher scores indicating greater survivor concerns (worse outcomes) and lower scores indicating fewer concerns (better outcomes).
From enrollment to the end of study at 12 months
Patient-Reported Outcome - Decision Regret Scale (DRS)
Time Frame: From enrollment to the end of study at 12 months
Decision regret will be assessed using the Decision Regret Scale (DRS), a validated patient-reported questionnaire measuring distress or remorse after a healthcare decision. Scores are transformed to a 0-100 scale, with higher scores indicating greater decision regret (worse outcome) and lower scores indicating less regret (better outcome).
From enrollment to the end of study at 12 months
Changes in thyroid biochemical markers over time, including:
Time Frame: From enrollment to the end of study at 12 months.

Thyroid-stimulating hormone (TSH)

Free T4 (if TSH abnormal)

Thyroglobulin

Thyroglobulin antibody levels
From enrollment to the end of study at 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Sangeet Ghai, MD, University Health Network - Toronto General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-5017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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