Radiofrequency ablation to shrink benign thyroid nodules

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

This project will try radiofrequency ablation to shrink symptomatic benign or autonomously functioning thyroid nodules in adults and see if it improves symptoms and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Ghent (other)
• Locations: 3 sites (Bruges and 2 other locations)
• Trial ID: NCT07237373 on ClinicalTrials.gov

What this trial studies

This is a multicenter prospective observational study of outpatient ultrasound-guided radiofrequency ablation (RFA) for symptomatic benign or autonomously functioning thyroid nodules. Participants undergo percutaneous RFA using a cooled electrode and the moving-shot technique, typically under local anesthesia, with procedure times of roughly 15–40 minutes. Patients complete the ThyPRO-39 quality-of-life questionnaire before treatment and at 1, 3, 6, and 12 months, and undergo ultrasound, symptom/cosmetic scoring, thyroid function blood tests, and safety monitoring at follow-up visits. Primary outcomes include change in health-related quality of life, nodule volume reduction, symptom relief, and procedure safety.

Who should consider this trial

Good fit: Adults with symptomatic benign thyroid nodules or autonomously functioning nodules confirmed by benign cytology or scintigraphy, who are medically stable (ECOG 0–1) and willing to attend outpatient follow-up visits, are ideal candidates.

Not a fit: Patients with purely cystic lesions, suspicious or malignant nodules, recent malignancy within two years, limited life expectancy, contralateral vocal cord paralysis, or on incompatible anticoagulation are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If successful, RFA could shrink nodules and reduce compressive or cosmetic symptoms while avoiding thyroid surgery and its associated risks.

How similar studies have performed: Previous clinical series and international guidelines (ETA, CIRSE) report that RFA can safely reduce nodule volume and improve symptoms, supporting its use as a nonsurgical option.

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

Where this trial is running

Bruges and 2 other locations

• AZ Sint-Jan Brugge — Bruges, Belgium (NOT_YET_RECRUITING)
• UZ Gent — Ghent, Belgium (RECRUITING)
• UZ Leuven — Leuven, Belgium (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Charlotte Harth, MD

Conditions: Benign Thyroid Nodule, benign thyroid nodule, radiofrequency ablation, interventional radiology, percutaneous thermoablation