Percutaneous Thermo-ablation for the Treatment of Benign Thyroid Nodules

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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

Eligibility criteria

Qualifiers

> 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.

Disqualifiers

<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.

Trial design

Treatments tested in this trial

  • Percutaneous radiofrequency ablation

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Ghent

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborator

AZ Sint-Jan AV

Collaborator