Cryoablation and RFA of Benign Thyroid Nodules: Pilot Study

Benign Thyroid Nodule Clinical Trial

Official title: Thermal Ablation of Benign Thyroid Nodules With Cryoablation or Radiofrequency

Status Recruiting

Clinical Trial Summary

This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation and a radiofrequency ablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of benign thyroid nodules with cryoablation will be directed to patients with benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. The cryoablation or RFA will be directed in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.

Clinical Trial Description

Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes more common when the thyroid is examined by ultrasound. The vast majority of nodules are benign and, over time, do not change considerably in size. The main treatment indications for a euthyroid patient with a benign thyroid nodule that is not hyperfunctioning are compression of the trachea or esophagus, growth of the nodule, and recurrence of a cystic nodule after aspiration. Other indications for treatment are neck discomfort, cosmetic concern, and patient anxiety about the lump. The main therapeutic options are surgery (unilateral lobectomy) and treatment with thyroxine. Thermal ablative therapy has become a treatment option for solid thyroid lesions, with extensive reports in the medical literature on safety and efficacy with laser and radiofrequency devices, including long-term follow-up studies (10 years). In our country, several radiofrequency thermal ablation (RFA) devices are available for use in the treatment of benign thyroid nodules, although some ablation devices do not have the manufacturer's registration for this purpose. Additionally, there is no record in the medical literature of the use of cryoablation devices for the ablation of benign thyroid nodules, although they are used for the treatment of tumor lesions in different sites (hepatic, renal, pulmonary, bone and cervical lymph nodes).The objective of this research is to evaluate, in a pilot study, the safety and efficacy of cryoablation in the treatment of benign thyroid nodules. Additionally, the same evaluation is possible using an RFA device not yet tested for this purpose. ;

Related Conditions & MeSH terms

• Benign Thyroid Nodule
• Thyroid Diseases
• Thyroid Nodule

• NCT number: NCT06014229
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Contact: Freitas
• Phone: 55 11 2661-7861
• Email: ricardo.freitas@hc.fm.usp.br
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Completion date: April 30, 2025