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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05142904
Other study ID # 2021-1798
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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