Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Reason given: Switched from RCT to observational prospective cohort due to termination of subsidy (delay due to insufficient inclusion-rate). Follow-up of RCT-arm will be completed. Patients can still be included in a observational cohort.
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Trial details
- Who runs it
- Rijnstate Hospital
- Trial code
- NCT05142904
- Record updated
- 17 July 2025
- Original description
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.Read full original descriptionShow less
Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Inclusion: 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: 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; Multifocal HTN; HTN > 50 mm; Presence of a medical device susceptible to disturbances caused by RFA generated currents; Uncorrectable haemorrhagic diathesis; Pregnant or breastfeeding women.