Actively Recruiting

Age: 18Years +
All Genders
ID07237373

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

Led by University Hospital, Ghent · Updated on 2026-04-29

50

Participants Needed

3

Research Sites

56 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

Benign thyroid nodules are common in adults and can cause symptoms like pressure, cosmetic concerns, or hyperthyroidism if they function autonomously. This observational study is designed to evaluate if radiofrequency ablation (RFA), a minimally invasive heat-based treatment, can safely reduce symptoms and improve quality of life in adults with symptomatic benign or autonomously functioning thyroid nodules. The study aims to answer how RFA affects health-related quality of life using the ThyPRO-39 questionnaire and whether it effectively decreases nodule size and related symptoms. Participants will receive RFA treatment, which involves inserting a cooled electrode needle guided by ultrasound into the thyroid nodule to deliver localized heat and cause tissue shrinkage without harming nearby areas. This outpatient procedure typically lasts 15 to 40 minutes and uses a moving shot technique for precise ablation. After treatment, participants attend follow-up visits at 1, 3, 6, and 12 months, undergoing ultrasound checks, symptom and cosmetic assessments, thyroid blood tests, and safety monitoring. Throughout the study, participants complete quality of life questionnaires before and after treatment at regular intervals. Researchers will measure nodule volume reduction, symptom changes, cosmetic improvements, thyroid function stability, and any treatment-related adverse events. The study collects comprehensive data to understand RFA's role in managing benign thyroid nodules, supporting its potential use as a less invasive alternative to surgery, with overall participation lasting at least one year after treatment.

CONDITIONS

Brief Title

Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Symptomatic benign thyroid nodules with compressive or cosmetic complaints OR autonomously functioning thyroid nodules with subclinical hyperthyreosis or thyrotoxicosis proven on scintigraphy
  • No limit on nodule size
  • Solid component greater than 20% and benign cytology (Bethesda II) confirmed in 1 or 2 separate cytological assessments (no biopsy required if "hot" nodule on scintigraphy)
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Purely cystic thyroid nodules
  • Severe comorbidities limiting life expectancy to less than 2 years
  • Diagnosis of malignancies within the last 2 years except for non-melanoma skin cancer and non-muscle invasive bladder cancer
  • Lack of compliance
  • Malignant or suspicious thyroid nodules or nodules forming a compressive lobar mass
  • Contralateral vocal cord paralysis
  • Anticoagulant therapy that cannot be suspended
  • Unresolvable coagulation disorders
  • Lack of patient consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for baseline evaluation including ultrasound, cytology, and thyroid function testing

Implementation

Duration - Single procedure lasting 15 to 40 minutes

Participants undergo percutaneous radiofrequency ablation using a cooled electrode needle under ultrasound guidance to treat benign thyroid nodules.

1 outpatient visit for the ablation procedure

Long-term Monitoring

Duration - 12 months

Participants are followed up to assess clinical effectiveness, safety, and quality of life after the ablation.

Follow-up visits at 1, 3, 6, and 12 months with assessments of nodule characteristics, thyroid function, patient-reported outcomes, and complications

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

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Research Team

C

Charlotte Harth, MD

L

Lien Van Cauwenberghe, MSc

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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Published Research Related To This Trial

Determining minimal important change for the thyroid-related quality of life questionnaire ThyPRO.

Selma Flora Nordqvist, Victor Brun Boesen, Åse Krogh Rasmussen...

https://pubmed.ncbi.nlm.nih.gov/33617467

Bethesda Classification and Cytohistological Correlation of Thyroid Nodules in a Brazilian Thyroid Disease Center.

Kassia B Reuters, Maria C O C Mamone, Elsa S Ikejiri...

https://pubmed.ncbi.nlm.nih.gov/30023345

European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS.

Gilles Russ, Steen J Bonnema, Murat Faik Erdogan...

https://pubmed.ncbi.nlm.nih.gov/29167761

Long-Term Efficacy of a Single Session of RFA for Benign Thyroid Nodules: A Longitudinal 5-Year Observational Study.

Maurilio Deandrea, Pierpaolo Trimboli, Francesca Garino...

https://pubmed.ncbi.nlm.nih.gov/30860579