Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules (RABITO)

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.

Study Overview

• Status: Recruiting
• Conditions: Radiofrequency Ablation; Thyroid Nodule, Toxic or With Hyperthyroidism; Autonomous Thyroid Function; Thyroid Nodule; Hyperthyroidism; Iodine Hyperthyroidism; Iodine Adverse Reaction
• Intervention / Treatment: Device: Radiofrequency ablation; Drug: Radioactive iodine; Drug: Radioactive iodine

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Manon MD van der Meeren, MD; Phone Number: 088 005 8888; Email: mvandermeeren@rijnstate.nl
• Study Contact Backup: Name: Wim Oyen, Prof.; Phone Number: 088 005 8888; Email: RABITOstudie@rijnstate.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NT Groningen
    • Recruiting
    • Martini Hospital
    • Contact: K Hoogenberg, MD, PhD
    • Contact: Email: hoogenk@mzh.nl
  • Gelderland
    • Almelo, Gelderland, Netherlands, 7609PP
      • Recruiting
      • Ziekenhuis Groep Twente
      • Contact: Sicco Braak; Email: s.braak@zgt.nl
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: Wim Oyen, Prof.; Phone Number: 088 005 8888; Email: RABITOstudie@rijnstate.nl
      • Contact: Manon van der Meeren, MD; Phone Number: 088 005 8888; Email: mvandermeeren@rijnstate.nl
      • Principal Investigator: Wim Oyen, Prof.
      • Sub-Investigator: Manon MD van der Meeren, MD
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818
      • Recruiting
      • Amphia Hospital
      • Contact: Charlotte Krol; Email: CKrol@amphia.nl
    • Eindhoven, Noord-Brabant, Netherlands, 5623EJ
      • Recruiting
      • Catharina hospital
      • Contact: jerome Kisters; Email: jerome.kisters@catharinaziekenhuis.nl
    • Helmond, Noord-Brabant, Netherlands, 5707HA
      • Recruiting
      • Elkerliek Hospital
      • Contact: Petri Kox; Email: pm.vangastel@elkerliek.nl
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • Recruiting
      • Amsterdam Umc, Location Vumc
      • Contact: Pim de Graaf, PhD; Phone Number: 020 444 4444; Email: p.degraaf@amsterdamumc.nl
      • Contact: Koen Dreijerink, MD; Phone Number: 020 444 4444; Email: k.dreijerink@amsterdamumc.nl
      • Principal Investigator: Pim de Graaf, PhD
    • Hoofddorp, Noord-Holland, Netherlands, 2134 TM Hoofddorp
      • Recruiting
      • Spaarne Gasthuis
      • Contact: J Boer, MD, PhD
      • Contact: Email: jboer@spaarnegasthuis.nl
  • Zuid Holland
    • Dordrecht, Zuid Holland, Netherlands, 3318AT
      • Recruiting
      • Albert Schweiter Hospital
      • Contact: Simone Hartong; Email: s.c.c.hartong@asz.nl
    • Zoetermeer, Zuid Holland, Netherlands, 2725 NA
      • Recruiting
      • Haga Ziekenhuizen
      • Contact: C Boot, MD, PhD
      • Contact: Email: c.boot2@hagaziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency ablation; Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.	Device: Radiofrequency ablation; Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.; Other Names: RFA; Ultrasound-guided radiofrequency ablation
Active Comparator: Radioactive iodine, study protocol; Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.	Drug: Radioactive iodine; I-131 according to standardized doses-calculation.; Other Names: I-131; Drug: Radioactive iodine; I-131 according to local standard.; Other Names: I-131
Other: Radioactive iodine, cohort; 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; I-131 according to standardized doses-calculation.; Other Names: I-131; Drug: Radioactive iodine; I-131 according to local standard.; Other Names: I-131

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate	Medication-free normalization of TSH, FT4 and FT3 levels	1 year post-intervention
Thyroid nodule volume	Volume of thyroid nodule assessed by ultrasound	Baseline, 6 and 12 months post-intervention
Treatment related adverse events	Number of adverse and serious adverse events	6 weeks and 3, 6 and 12 months post-intervention
Thyroid related quality of life	Thyroid related quality of life assessed by ThyPro questionnaire	Baseline, 6 and 12 months after intervention
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
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.
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Use of hospital resources	According to medical records	1 year post-intervention
Medical consumption	iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)	1 year post-intervention
Use of healthcare resources	iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)	1 year post-intervention
Cumulative cost	Based on Rijnstate price estimates	1 year post-intervention
Fractional nodal uptake	Assessed by I-123 or I-131 scintigraphy	1 year post-intervention
Treatment related auto-immunity	Assessed by thyroid antibodies	Baseline and 1 year post-intervention

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; University of Twente; Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Hyperthyroidism; Thyroid Nodule; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine; Cadexomer iodine
• Other Study ID Numbers: 2021-1798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No