Radiofrequency ablation for small, low-risk papillary thyroid cancer
Tests heat treatment with radiofrequency ablation in adults with small papillary thyroid cancer.
Key facts
- Who runs it
- University Health Network, Toronto
- Where
- Toronto, CanadaSee the site
- Trial code
- Registry title
- Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 5 Feb 2026
- Expected to end
- 1 Jul 2027
- Type of study
- Interventional
- Treatments tested
- Radiofrequency Ablation of Papillary Thyroid Cancer
- VIVA combo RF Generator with Coagulation Electrode
- Record updated
- 19 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a small, low-risk papillary thyroid cancer that has not spread outside the thyroid. They will be treated with radiofrequency ablation (RFA).
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Papillary thyroid cancer confirmed by biopsy, each tumor up to 2.0 cm (0.8 in), only inside the thyroid, with no spread to lymph nodes or distant organs (T1b or smaller, N0 or Nx, M0). The tumor must be safely away from critical structures (more than 2 mm) or reachable with hydrodissection.
- Earlier treatment
- People who cannot have surgery because of other illnesses, or who refuse surgery. No earlier thyroid surgery or ablation at the tumor site.
Main reasons for not taking part
- Cancer spread to lymph nodes or distant organs
- Tumor growing outside the thyroid, or with extensive calcification
- Aggressive thyroid cancer types such as anaplastic or poorly differentiated
- Pregnant or breastfeeding at enrollment
- Pacemaker or other implanted electrical device, or a neck infection at the time of ablation
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous thyroid surgery or ablation (RFA, ethanol, laser, or microwave) at the index tumor site
- Bleeding diathesis or use of anticoagulants that cannot be discontinued safely prior to RFA
- Severe cervical anatomy distortion (prior neck surgery or radiation with distorted anatomy that prevents safe RFA
- Known diagnosis of anaplastic, poorly differentiated, or other aggressive thyroid cancer variants
- Severe comorbid illness that limits life expectancy to less than 5 years
- Infection in the neck including skin infection or thyroiditis at time of planned ablation
- 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
- Pregnant or breastfeeding at the time of enrollment
- Inability to adhere to study follow-up schedule or procedures or lacking decision-making capacity
- Implanted electrical devices such as pacemakers or neurostimulators
Where in Canada
- University Health Network - Princess Margaret Cancer CentreToronto, CanadaContact: Sangeet Ghai, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Radiofrequency Ablation (RFA) for Low-Risk Papillary Thyroid CancerTreatment being tested
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
Treatment: Radiofrequency Ablation of Papillary Thyroid Cancer and VIVA combo RF Generator with Coagulation Electrode
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Radiofrequency ablation for small, low-risk papillary thyroid cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 May 2026