Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

NCT07237373 | Recruiting

• 1 other identifier: ONZ-2025-0427
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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

Conditions

Benign Thyroid Nodule

Keywords

benign thyroid nodule; radiofrequency ablation; interventional radiology; percutaneous thermoablation

Outcome Measures

Primary Outcomes (1)

• Health related Quality Of Life (HRQoL)

  HRQoL will be assessed by the change in Thyroid-Related Patient-Reported Outcome 39 (ThyPRO-39) score from baseline to 1-year follow-up. The ThyPRO-39 is a thyroid-specific quality of life instrument covering 13 domains of QoL validated for patients with benign thyroid disease. The ThyPRO-39 includes scales assessing the following: goiter symptoms, eye symptoms, hyperthyroid symptoms, hypothyroid symptoms, tiredness, cognitive complaints, anxiety, depressivity, emotional susceptibility, impaired social life, impaired daily life, appearance, and overall QoL. Each item is rated on a Likert scale (0-4) from 0 = "no symptoms/problems" to 4 = "severe symptoms/problems." Scores are then transformed to yield 13 0-100 scales, where a higher score indicates worse health-related QoL

  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

Secondary Outcomes (6)

• Symptom score

  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.

• Cosmetic score

  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.

• Number of Participants with Treatment-Related Adverse Events

  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.

• Volume Reduction Rate (VRR)

  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.

• Technical efficacy

  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.

Study Arms (1)

Benign thyriod nodules

Subjects with symptomatic benign thyroid nodules with compressive/cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy.

Device: Percutaneous radiofrequency ablation

Interventions

Percutaneous radiofrequency ablation DEVICE

RFA uses an electric field, produced by a radiofrequency generator connected to an internally cooled electrode needle, leading to frictional agitation at the ionic level and to heat generation (Joule effect). The electrode is introduced under US guidance into the target nodule, and a continuous repositioning of the applicator ("moving shot" or "multiple overlapping shot" technique). The localized heating causes necrosis and shrinkage of the thyroid nodule without damaging surrounding tissues. The appearance of hyperechoic signals close to the electrode tip indicates the development of tissue changes and air formation, while a steep rise in tissue impedance demonstrates the achievement of tissue necrosis

Also known as: RFA, radiofrequency ablation

Benign thyriod nodules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from the following Belgian hospitals: Ghent University Hospital, University Hospital Leuven, AZ Sint Jan Brugge.

You may qualify if:

• \> 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 may not qualify if:

• \<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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• AZ Sint-Jan AV: collaborator

Study Sites (3)

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

NOT YET RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

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MeSH Terms

Interventions

Catheter Ablation; Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Charlotte Harth, MD

CONTACT

+32 9 332 0450; studies.vinrad@uzgent.be

Lien Van Cauwenberghe, MSc

CONTACT

+32 9 332 0450; lien.vancauwenberghe@uzgent.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

BE (3)