Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

Launched by RIJNSTATE HOSPITAL · Dec 2, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for people with hyperthyroidism caused by a solitary hyperactive thyroid nodule. The two treatments being studied are radiofrequency ablation (RFA), which uses heat to destroy the nodule, and I-131 (radioactive iodine), which is a common treatment for hyperthyroidism. The goal is to see which treatment is more effective and has fewer side effects.

To participate in the trial, you need to be over 18 years old and diagnosed with hyperthyroidism due to a single active thyroid nodule. There are some specific medical conditions that would make you ineligible, such as having multiple nodules or certain digestive issues. If you qualify and decide to join, you will receive one of the two treatments and be monitored throughout the study. It’s important to know that the trial is currently recruiting participants, so there is an opportunity to get involved if you meet the criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years
• * Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics:
• • Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels
• • Anti-TSH antibody negative
• • Solitary HTN confirmed by a diagnostic I-123 scintigraphy, corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration \< 75%, nodule size \<50 mm.
• • Treatment with RAI indicated, and eligible for RFA treatment
• • Signed informed consent Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group.
• 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
• • Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility
• • Uncorrectable haemorrhagic diathesis
• • Pregnant or breastfeeding women