Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

Radiofrequency Ablation Clinical Trial

— RABITO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142904
• Other study ID #: 2021-1798
• Status: Recruiting
• Phase: Phase 3
• Start date: November 17, 2021
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: Manon MD van der Meeren, MD
• Phone: 088 005 8888
• Email: mvandermeeren[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperthyroidism
• Radiofrequency Ablation
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Radiofrequency ablation
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.

Drug:
• Radioactive iodine
I-131 according to standardized doses-calculation.
• Radioactive iodine
I-131 according to local standard.

Locations

Country	Name	City	State
Netherlands	Ziekenhuis Groep Twente	Almelo	Gelderland
Netherlands	Amsterdam UMC, location VUMC	Amsterdam	Noord-Holland
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Amphia Hospital	Breda	Noord-Brabant
Netherlands	Albert Schweiter Hospital	Dordrecht	Zuid Holland
Netherlands	Catharina Hospital	Eindhoven	Noord-Brabant
Netherlands	Martini Hospital	Groningen
Netherlands	Elkerliek Hospital	Helmond	Noord-Brabant
Netherlands	Spaarne Gasthuis	Hoofddorp	Noord-Holland
Netherlands	Haga Ziekenhuizen	Zoetermeer	Zuid Holland

Sponsors (4)

Lead Sponsor	Collaborator
Rijnstate Hospital	Amsterdam UMC, University of Twente, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	Baseline, 6 and 12 months after intervention
Other	Use of hospital resources	According to medical records	1 year post-intervention
Other	Medical consumption	iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)	1 year post-intervention
Other	Use of healthcare resources	iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)	1 year post-intervention
Other	Cumulative cost	Based on Rijnstate price estimates	1 year post-intervention
Other	Fractional nodal uptake	Assessed by I-123 or I-131 scintigraphy	1 year post-intervention
Other	Treatment related auto-immunity	Assessed by thyroid antibodies	Baseline and 1 year post-intervention
Primary	Hypothyroidism	Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)	1 year post-intervention
Secondary	Cure rate	Medication-free normalization of TSH, FT4 and FT3 levels	1 year post-intervention
Secondary	Thyroid nodule volume	Volume of thyroid nodule assessed by ultrasound	Baseline, 6 and 12 months post-intervention
Secondary	Treatment related adverse events	Number of adverse and serious adverse events	6 weeks and 3, 6 and 12 months post-intervention
Secondary	Thyroid related quality of life	Thyroid related quality of life assessed by ThyPro questionnaire	Baseline, 6 and 12 months after intervention
Secondary	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
Secondary	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.
Secondary	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