Radiofrequency Ablation for Small Low-Risk Papillary Thyroid Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm pilot trial evaluates the feasibility, safety, and effectiveness of ultrasound-guided radiofrequency ablation as a curative treatment for biopsy-proven papillary thyroid cancer under 2 cm. Thirty adults will undergo RFA with curative intent and be followed for up to 12 months with clinical visits, neck ultrasounds, blood tests, voice assessments, and patient-reported outcomes; a biopsy at 6–12 months will assess local control. The study aims to determine the local cure rate and safety, while also observing post-ablation imaging features and quality of life. Standard thyroid cancer risks and the potential benefits and limitations of a less invasive approach will be discussed with participants who meet eligibility criteria. Participants are adults with intrathyroidal, small PTC who are either unfit for surgery, refuse it, or prefer treatment over active surveillance.

Why it matters

Who can join: the full rules

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

Where it's running

• University Health Network - Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sangeet Ghai, MD — University Health Network - Toronto General Hospital
• Study coordinator: Kateri Corr
• Email: kateri.corr@uhn.ca
• Phone: 416-500-5737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.