Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules: a Prospective Multicentric Study
University Hospital, Ghent
50 participants
Mar 3, 2026
OBSERVATIONAL
Conditions
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 12 months with: * Ultrasound assessments of the thyroid nodule * Symptom and cosmetic scoring * Blood tests to monitor thyroid function * Safety checks for possible complications
Eligibility
Inclusion Criteria5
- > 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 Criteria10
- <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 bladder cancer.
- Lack of compliance
- Malignant or suspicious thyroid nodules or nodules that are confluent in a compressive lobar mass
- Contralateral vocal cord paralysis
- Anticoagulant therapy that could not be suspended
- Unresolvable coagulation disorders
- Absence of consent of the patient
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Interventions
RFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator ("moving shot" or "multiple overlapping shot" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT07237373