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ClinicalTrials.gov ID

NCT07237373

Lead Sponsor

University Hospital, GhentOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Aug 26, 2026Actual

Start Date

Mar 3, 2026Actual

Primary Completion Date

Feb 28, 2030Estimated

Completion Date

Apr 1, 2031Estimated

Official Title

Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules: a Prospective Multicentric Study

Brief 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

Detailed Description

Benign thyroid nodules are highly prevalent in the adult population. While most remain asymptomatic, some patients experience compressive symptoms, cosmetic concerns, or hyperthyroidism due to autonomously functioning nodules. Standard therapy is hemithyroidectomy or total thyroidectomy, which is effective but associated with risks such as hypothyroidism, nerve injury, visible scarring, and increased health care costs. As a result, minimally invasive, nonsurgical alternatives are being actively investigated.

Radiofrequency ablation (RFA) is a percutaneous thermoablation technique performed under ultrasound guidance using a cooled electrode needle. Heat generated at the electrode tip induces localized necrosis within the target nodule, leading to progressive shrinkage while sparing surrounding thyroid tissue. In most cases, the procedure is carried out under local anesthesia in an outpatient setting, with an average duration of 15-40 minutes. The "moving shot" technique is typically employed, allowing precise ablation of large nodules in multiple overlapping steps.

International guidelines from the European Thyroid Association (ETA) and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recommend RFA as an alternative for patients with benign thyroid nodules who present with compressive symptoms, cosmetic complaints, or autonomously functioning thyroid nodules not suitable for surgery or radioactive iodine.

This multicenter prospective observational study will investigate the clinical effectiveness and safety of RFA in routine practice. The primary outcome is health-related quality of life (HRQoL), assessed by the validated ThyPRO-39 instrument. Secondary outcomes include technical efficacy (≥50% volume reduction rate), symptom and cosmetic improvement, stability of thyroid function, and safety endpoints based on the CIRSE classification of complications.

Participants will undergo standardized baseline evaluation including ultrasound, cytology, and thyroid function testing. Follow-up visits are scheduled at 1, 3, 6, and 12 months, with systematic assessments of nodule characteristics, laboratory values, patient-reported outcomes, and complications. Technical success and regrowth will be defined according to internationally accepted thresholds.

By collecting prospective multicenter data, this study aims to generate high-quality evidence on the role of RFA in the treatment of benign thyroid nodules. The results are expected to strengthen the scientific and economic case for adopting RFA as a reimbursable, minimally invasive therapy in clinical practice, while contributing to the long-term body of literature on patient-centered outcomes in thyroid disease.

• Benign Thyroid Nodule

• Percutaneous radiofrequency ablation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

University Hospital, GhentOTHER

Collaborators

Universitaire Ziekenhuizen KU LeuvenOTHER

AZ Sint-Jan AVOTHER

charlotte.harth@uzgent.be+32 9 332 0450