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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \> 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.

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge
NOT_YET_RECRUITING
Bruges
UZ Gent
RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
Contact Information
Primary
Charlotte Harth, MD
studies.vinrad@uzgent.be
+32 9 332 0450
Backup
Lien Van Cauwenberghe, MSc
lien.vancauwenberghe@uzgent.be
+32 9 332 0450
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2031-04-01
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: AZ Sint-Jan AV, Universitaire Ziekenhuizen KU Leuven
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov