Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules

2021-1798

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

2021-11-17

2027-12-01

2028-12-01

Recruiting

Early phase I

232

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre 1:1 randomized clinical trial where patients are allocated to either radiofrequency ablation (RFA) or radioactive iodine (RAI) (I-131). Patients who are not suitable for randomization (e.g. no informed consent or contra-indication for RFA) are asked for consent to participate in a prospective cohort where participants are asked to fill out questionaires and data is collected.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 232, 'type': 'ESTIMATED'}}

2024-04-11