Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules. The main questions it aims to answer are
| Condition(s) | Benign Thyroid Nodule |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this observational study is to learn if radiofrequency ablation (RFA), a minimally invasive thermoablation technique, can safely reduce symptoms and improve quality of life in adults with symptomatic benign thyroid nodules or autonomously functioning thyroid nodules. The main questions it aims to answer are: * Does RFA improve health-related quality of life (HRQoL) as measured by the ThyPRO-39 questionnaire? * Does RFA effectively reduce nodule volume and related symptoms (compressive or cosmetic)? Participants will: * Undergo a radiofrequency ablation procedure of the thyroid nodule performed under ultrasound guidance in an outpatient setting. * Complete quality of life questionnaires (ThyPRO-39) before treatment and at follow-up visits. Attend follow-up visits at 1, 3, 6, and |
| Who can participate | Inclusion Criteria: * \> 18 years old * 'Eastern Cooperative Oncology Group' (ECOG) performance status of 0 or 1 * Symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy. * No cutoff in nodule size. * Solid component \> 20%, and benign cytology (Bethesda II) in 1 (EUTIRADS 3) or 2 (EUTIRADS 4) separate cytological assessments. In the case of a proven "hot" nodule on scintigraphy, no biopsy is required. Exclusion Criteria: * \<18y * Purely cystic nodule * Severe comorbidity which limits the further life expectancy of the patient to \< 2 years (opinion of the physician) * Malignancies \<2 years ago except for non-melanoma skin cancer and non-muscle invasive bl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Ghent |
| Locations | Bruges, Belgium; Ghent, Belgium; Leuven, Belgium |
| Start date | 2026-03-03 |
| NCT ID | NCT07237373 |
| Official listing | https://clinicaltrials.gov/study/NCT07237373 |