Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules (NCT05142904) | Clinical Trial Compass
TerminatedPhase 3
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Stopped: 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.
Netherlands40 participantsStarted 2021-11-17
Plain-language summary
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Who can participate
Age range18 Years
SexALL
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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