About this trial
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 criteria
Qualifiers
> 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.
Disqualifiers
<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.
Trial design
Treatments tested in this trial
- Percutaneous radiofrequency ablation
Treatment groups
Sponsors and collaborators
University Hospital, Ghent
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
AZ Sint-Jan AV
Collaborator