Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
NCT ID: NCT05142904
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
40 participants
INTERVENTIONAL
2021-11-17
2024-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency ablation
Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.
Radiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Radioactive iodine, study protocol
Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
Radioactive iodine
I-131 according to standardized doses-calculation.
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).
Radioactive iodine
I-131 according to local standard.
Interventions
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Radiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Radioactive iodine
I-131 according to standardized doses-calculation.
Radioactive iodine
I-131 according to local standard.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
University of Twente
OTHER
Amsterdam UMC
OTHER
Rijnstate Hospital
OTHER
Responsible Party
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Locations
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Ziekenhuis Groep Twente
Almelo, Gelderland, Netherlands
Gelre Hospitals
Apeldoorn, Gelderland, Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Laurentius Hospital
Roermond, Limburg, Netherlands
Amphia Hospital
Breda, North Brabant, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Elkerliek Hospital
Helmond, North Brabant, Netherlands
Amsterdam UMC, location VUMC
Amsterdam, North Holland, Netherlands
OLVG
Amsterdam, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Albert Schweiter Hospital
Dordrecht, South Holland, Netherlands
Haaglanden MC
The Hague, South Holland, Netherlands
Haga Ziekenhuizen
Zoetermeer, South Holland, Netherlands
Martini Hospital
Groningen, , Netherlands
Countries
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Other Identifiers
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2021-1798
Identifier Type: -
Identifier Source: org_study_id
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