ltrasound-guided Radiofrequency Ablation versus radioactive iodine as Treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules

Phase 3

Recruiting

• Conditions: hyperactive nodule; thyroid lump; 10043739

• Registration Number: NL-OMON54080
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 232

Inclusion Criteria

- Age > 18 years
- Hyperthyroidism or subclinical hyperthyroidims caused by a solitary
hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid
gland, or in a multinodular goitre (MNG)
- Treatment with RAI indicated and eligible for RFA
- Signed informed consent

Exclusion Criteria

- Multifocal HTN
- HTN > 50 mm
- Presence of a medical device susceptible to disturbances caused by RFA
generated currents
- Patients with physical or behavioural disorders that preclude safe isolation
in radiation protection rooms, or safe RFA procedure under local anesthesia
- Uncorrectable hemorrhagic diathesis
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of irreversible hypothyroidism</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- one year cure rate<br /><br>- course of thyroid function<br /><br>- nodule volume<br /><br>- treatment related thyroiditis<br /><br>- adverse effects<br /><br>- standardized iodine versus local iodine<br /><br>- cost effectiveness<br /><br>- (thyroid related) quality of life<br /><br>- factors for implemantation</p><br>