Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

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

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

Conditions
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Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction

Intervention / Treatment
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* Device: Radiofrequency ablation
* Drug: Radioactive iodine
* Drug: Radioactive iodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation<br>Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique. | Device: Radiofrequency ablation<br>* Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.<br>* Other names: Ultrasound-guided radiofrequency ablation;|
| Active Comparator: Radioactive iodine, study protocol<br>Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation. | Drug: Radioactive iodine<br>* I-131 according to standardized doses-calculation.<br>* Other names: I-131;|
| Other: Radioactive iodine, cohort<br>This group contains patients who are not randomized and have given informed consent undergo treatment with radioactive iodine (I-131) according to local standard (e.g. fixed dose or dose-calculation based on iodine uptake and thyroid nodule mass). | Drug: Radioactive iodine<br>* I-131 according to local standard.<br>* Other names: I-131;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothyroidism | Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels) | 1 year post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | Medication-free normalization of TSH, FT4 and FT3 levels | 1 year post-intervention | 
| Thyroid nodule volume | Volume of thyroid nodule assessed by ultrasound | Baseline, 6 and 12 months post-intervention | 
| Treatment related adverse events | Number of adverse and serious adverse events | 6 weeks and 3, 6 and 12 months post-intervention | 
| Thyroid related quality of life | Thyroid related quality of life assessed by ThyPro questionnaire | Baseline, 6 and 12 months after intervention | 
| Cost-effectiveness | Determined as the incremental costs in Euros per quality adjusted life year (QALY) | Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention | 
| Course of thyroid function | Assessed by TSH, FT4 and FT3 an medication use | Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years. | 
| Short-term patient satisfaction | Assessed by interviews, satisfaction questionnaire and pain scoring by visual analog scale (VAS, a scale ranging from 0-10 represented as a line with 0 on the left end indicating 'no pain' and 10 on the right end, indicating 'the worst pain'). | 1 week and 1 year post-intervention |