A Phase 3 interventional study of Radiofrequency ablation and Radioactive iodine in Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function and Thyroid Nodule; Hyperthyroidism, sponsored by Rijnstate Hospital. Terminated at 14 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Rijnstate Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.
Device: Radiofrequency ablation
Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
Drug: Radioactive iodine
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
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Also known as: RFA, Ultrasound-guided radiofrequency ablation
I-131 according to standardized doses-calculation.
Also known as: I-131
I-131 according to local standard.
Also known as: I-131
Hypothyroidism
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
Time frame: 1 year post-intervention
Cure rate
Medication-free normalization of TSH, FT4 and FT3 levels
Time frame: 1 year post-intervention
Thyroid nodule volume
Volume of thyroid nodule assessed by ultrasound
Time frame: Baseline, 6 and 12 months post-intervention
Treatment related adverse events
Number of adverse and serious adverse events
Time frame: 6 weeks and 3, 6 and 12 months post-intervention
Thyroid related quality of life
Thyroid related quality of life assessed by ThyPro questionnaire
Time frame: Baseline, 6 and 12 months after intervention
Cost-effectiveness
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
Time frame: 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
Time frame: 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').
Time frame: 1 week and 1 year post-intervention
Health outcomes and quality of life
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)
Time frame: Baseline, 6 and 12 months after intervention
Use of hospital resources
According to medical records
Time frame: 1 year post-intervention
Medical consumption
iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)
Time frame: 1 year post-intervention
Use of healthcare resources
iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)
Time frame: 1 year post-intervention
Cumulative cost
Based on Rijnstate price estimates
Time frame: 1 year post-intervention
Fractional nodal uptake
Assessed by I-123 or I-131 scintigraphy
Time frame: 1 year post-intervention
Treatment related auto-immunity
Assessed by thyroid antibodies
Time frame: Baseline and 1 year post-intervention
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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