Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rijnstate Hospital
• Collaborators: Amsterdam UMC; University of Twente; ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Cadexomer iodine; Iodine

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