Clinical trial · Interventional
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autonomous Thyroid Function | — | UNRESOLVED | — |
| Iodine Adverse Reaction | — | UNRESOLVED | — |
| Iodine Hyperthyroidism | — | UNRESOLVED | — |
| Radiofrequency Ablation | — | UNRESOLVED | — |
| Thyroid Nodule; Hyperthyroidism | — | UNRESOLVED | — |
| Thyroid Nodule, Toxic or With Hyperthyroidism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radioactive iodine | Drug | Radioactive Iodine | ALIAS |
| Radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation
- description
- Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.
- interventionNames
- Device: Radiofrequency ablation
- type
- ACTIVE_COMPARATOR
- label
- Radioactive iodine, study protocol
- description
- Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
- interventionNames
- Drug: Radioactive iodine
- type
- OTHER
- label
- Radioactive iodine, cohort
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available