Actively Recruiting
Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
Led by University Hospital, Ghent · Updated on 2026-04-29
50
Participants Needed
3
Research Sites
265 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules
Who Can Participate
Eligibility Criteria
You may qualify if you...
- > 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.
You will not qualify if you...
- <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
AI-Screening
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Trial Site Locations
Total: 3 locations
1
AZ Sint-Jan Brugge
Bruges, Belgium, 8000
Not Yet Recruiting
2
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
3
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
Research Team
C
Charlotte Harth, MD
CONTACT
L
Lien Van Cauwenberghe, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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