Thyroid Nodule, Toxic or With HyperthyroidismPhase 3RABITONCT05142904
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
A Phase 3 study testing Radiofrequency ablation and Radioactive iodine in people with Thyroid Nodule, Toxic or With Hyperthyroidism and Autonomous Thyroid Function, run by Rijnstate Hospital at 14 sites in Netherlands.
Trial summary
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism
- What is being tested?
- Radiofrequency ablation and Radioactive iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 14 sitesNetherlands
- Study dates
- 17 Nov 2021to 1 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Netherlands14 sites
Ziekenhuis Groep Twente
Almelo, Gelderland, 7609PP
Amsterdam UMC, location VUMC
Amsterdam, North Holland, 1081HV
OLVG
Amsterdam, North Holland, 1091AC
Gelre Hospitals
Apeldoorn, Gelderland, 7334DZ
Rijnstate Hospital
Arnhem, Gelderland, 6815AD
Amphia Hospital
Breda, North Brabant, 4818
Albert Schweiter Hospital
Dordrecht, South Holland, 3318AT
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Martini Hospital
Groningen, 9728 NT Groningen
Elkerliek Hospital
Helmond, North Brabant, 5707HA
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM Hoofddorp
Laurentius Hospital
Roermond, Limburg, 6043CV
Haaglanden MC
The Hague, South Holland, 2512VA
Haga Ziekenhuizen
Zoetermeer, South Holland, 2725 NA
About this study
Official title: Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
- Conditions
- Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction
- Being tested
- Radiofrequency ablation, Radioactive iodine
- Medical subject headings
- Thyroid Nodule, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationDevice
Also called RFA, Ultrasound-guided radiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Radioactive iodineDrug
Also called I-131
I-131 according to standardized doses-calculation.
Radioactive iodineDrug
Also called I-131
I-131 according to local standard.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation | Experimental | Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique. Receives: Device: Radiofrequency ablation |
| Radioactive iodine, study protocol | Active comparator | Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation. Receives: Drug: Radioactive iodine |
| Radioactive iodine, cohort | Other | 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). Receives: Drug: Radioactive iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothyroidism
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
Measured: 1 year post-intervention
Secondary outcomes (7)
Cure rate
Medication-free normalization of TSH, FT4 and FT3 levels
Measured: 1 year post-intervention
Thyroid nodule volume
Volume of thyroid nodule assessed by ultrasound
Measured: Baseline, 6 and 12 months post-intervention
Treatment related adverse events
Number of adverse and serious adverse events
Measured: 6 weeks and 3, 6 and 12 months post-intervention
Thyroid related quality of life
Thyroid related quality of life assessed by ThyPro questionnaire
Measured: Baseline, 6 and 12 months after intervention
Cost-effectiveness
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
Measured: 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
Measured: 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').
Measured: 1 week and 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start17 Nov 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule, Toxic or With HyperthyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, University of Twente, Amsterdam UMC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142904
- Sponsor's protocol ID
- 2021-1798
- Acronym
- RABITO
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2021
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05142904
- Acronym / sponsor ID
- RABITO / 2021-1798
- Conditions
- Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, University of Twente, Amsterdam UMC
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation | Experimental | Device: Radiofrequency ablationPatients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique. |
| Radioactive iodine, study protocol | Active comparator | Drug: Radioactive iodinePatients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation. |
| Radioactive iodine, cohort | Other | Drug: Radioactive iodineThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationAlso: RFA, Ultrasound-guided radiofrequency ablationUltrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule. | Device | Radiofrequency ablation |
| Radioactive iodineAlso: I-131I-131 according to standardized doses-calculation. | Drug | Radioactive iodine, study protocol |
| Radioactive iodineAlso: I-131I-131 according to local standard. | Drug | Radioactive iodine, cohort |
Primary outcome
Hypothyroidism
Time frame: 1 year post-intervention
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
7 secondary outcomes
Cure rate
Time frame: 1 year post-intervention
Thyroid nodule volume
Time frame: Baseline, 6 and 12 months post-intervention
Treatment related adverse events
Time frame: 6 weeks and 3, 6 and 12 months post-intervention
Thyroid related quality of life
Time frame: Baseline, 6 and 12 months after intervention
Cost-effectiveness
Time frame: Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention
Course of thyroid function
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
Time frame: 1 week and 1 year post-intervention
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiofrequency ablation and Radioactive iodine in people with Thyroid Nodule, Toxic or With Hyperthyroidism and Autonomous Thyroid Function, run by Rijnstate Hospital at 14 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothyroidism (time frame: 1 year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.