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Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Ghent
NCT07237373 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 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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What it tests

  • Percutaneous radiofrequency ablation
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Where

3 sites
AZ Sint-Jan Brugge
Bruges, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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