Recruiting

Radiofrequency Ablation

Sponsor:

University Health Network, Toronto

Code:

NCT07376837

Conditions

Thyroid Papillary Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiofrequency Ablation of Papillary Thyroid Cancer

VIVA combo RF Generator with Coagulation Electrode

Study Details

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

Study ID

NCT07376837

Start date

Feb 5, 2026

Status verified date

May, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

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

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

Primary outcome measure

  • Local Cure Rate of Papillary Thyroid Cancer (PTC) following Radiofrequency [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Kateri Corr

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

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

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

Locations

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Sangeet Ghai, MD

sangeet.ghai@uhn.ca

Kateri Corr

416-946-4501kateri.corr@uhn.ca

Principal Investigator:

Sangeet Ghai, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-19.