RABITO: Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Study Details
Study Description
Brief Summary
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Radiofrequency ablation Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique. |
Device: Radiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Other Names:
|
| Active Comparator: Radioactive iodine, study protocol Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation. |
Drug: Radioactive iodine
I-131 according to standardized doses-calculation.
Other Names:
|
| Other: Radioactive iodine, cohort 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
I-131 according to local standard.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Hypothyroidism [1 year post-intervention]
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
Secondary Outcome Measures
- Cure rate [1 year post-intervention]
Medication-free normalization of TSH, FT4 and FT3 levels
- Thyroid nodule volume [Baseline, 6 and 12 months post-intervention]
Volume of thyroid nodule assessed by ultrasound
- Treatment related adverse events [6 weeks and 3, 6 and 12 months post-intervention]
Number of adverse and serious adverse events
- Thyroid related quality of life [Baseline, 6 and 12 months after intervention]
Thyroid related quality of life assessed by ThyPro questionnaire
- Cost-effectiveness [Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention]
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
- Course of thyroid function [Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.]
Assessed by TSH, FT4 and FT3 an medication use
- Short-term patient satisfaction [1 week and 1 year post-intervention]
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').
Other Outcome Measures
- Health outcomes and quality of life [Baseline, 6 and 12 months after intervention]
Assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire. ( questions in 5 dimensions with 3 response levels, a higher score representing a worse outcome)
- Use of hospital resources [1 year post-intervention]
According to medical records
- Medical consumption [1 year post-intervention]
iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)
- Use of healthcare resources [1 year post-intervention]
iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)
- Cumulative cost [1 year post-intervention]
Based on Rijnstate price estimates
- Fractional nodal uptake [1 year post-intervention]
Assessed by I-123 or I-131 scintigraphy
- Treatment related auto-immunity [Baseline and 1 year post-intervention]
Assessed by thyroid antibodies
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rijnstate Hospital | Arnhem | Gelderland | Netherlands | 6815AD |
| 2 | Amsterdam UMC, location VUMC | Amsterdam | Noord-Holland | Netherlands | 1081HV |
Sponsors and Collaborators
- Rijnstate Hospital
- ZonMw: The Netherlands Organisation for Health Research and Development
- University of Twente
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-1798