Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

Phase 3

Recruiting

• Conditions: Radiofrequency Ablation; Thyroid Nodule, Toxic or With Hyperthyroidism; Thyroid Nodule; Hyperthyroidism; Autonomous Thyroid Function; Iodine Hyperthyroidism; Iodine Adverse Reaction
• Interventions: Drug: Radioactive iodine; Device: Radiofrequency ablation

• Registration Number: NCT05142904
• Lead Sponsor: Rijnstate Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-05
• Study Start: 2021-11-17
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radioactive iodine, study protocol	Radioactive iodine	Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
Radioactive iodine, cohort	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).
Radiofrequency ablation	Radiofrequency ablation	Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.

Primary Outcome Measures

Name	Time	Method
Hypothyroidism	1 year post-intervention	Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)

Secondary Outcome Measures

Name	Time	Method
Cure rate	1 year post-intervention	Medication-free normalization of TSH, FT4 and FT3 levels
Treatment related adverse events	6 weeks and 3, 6 and 12 months post-intervention	Number of adverse and serious adverse events
Course of thyroid function	Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.	Assessed by TSH, FT4 and FT3 an medication use
Short-term patient satisfaction	1 week and 1 year post-intervention	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').
Thyroid nodule volume	Baseline, 6 and 12 months post-intervention	Volume of thyroid nodule assessed by ultrasound
Thyroid related quality of life	Baseline, 6 and 12 months after intervention	Thyroid related quality of life assessed by ThyPro questionnaire
Cost-effectiveness	Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention	Determined as the incremental costs in Euros per quality adjusted life year (QALY)

Trial Locations

Locations (14)

Laurentius Hospital; 🇳🇱 Roermond, Limburg, Netherlands

Elkerliek Hospital; 🇳🇱 Helmond, Noord-Brabant, Netherlands

Albert Schweiter Hospital; 🇳🇱 Dordrecht, Zuid Holland, Netherlands

OLVG; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Noord-Holland, Netherlands

Ziekenhuis Groep Twente; 🇳🇱 Almelo, Gelderland, Netherlands

Amphia Hospital; 🇳🇱 Breda, Noord-Brabant, Netherlands

Haga Ziekenhuizen; 🇳🇱 Zoetermeer, Zuid Holland, Netherlands

Gelre Hospitals; 🇳🇱 Apeldoorn, Gelderland, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Amsterdam UMC, location VUMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Haaglanden MC; 🇳🇱 Den Haag, Zuid Holland, Netherlands

Martini Hospital; 🇳🇱 Groningen, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands