Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules (NCT07237373) | Clinical Trial Compass
RecruitingNot Applicable
Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
Belgium50 participantsStarted 2026-03-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Health related Quality Of Life (HRQoL)
Timeframe: From baseline (before treatment) to 12 months after the radiofrequency ablation procedure, with assessments at baseline, 1 month, 3 months, 6 months, and 12 months