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

Primary Purpose

Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Radiofrequency ablation
Radioactive iodine
Radioactive iodine
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule, Toxic or With Hyperthyroidism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Groep TwenteRecruiting
  • Rijnstate HospitalRecruiting
  • Amphia HospitalRecruiting
  • Catharina HospitalRecruiting
  • Elkerliek HospitalRecruiting
  • Amsterdam UMC, location VUMCRecruiting
  • Albert Schweiter HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Radiofrequency ablation

Radioactive iodine, study protocol

Radioactive iodine, cohort

Arm Description

Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.

Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.

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).

Outcomes

Primary Outcome Measures

Hypothyroidism
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)

Secondary Outcome Measures

Cure rate
Medication-free normalization of TSH, FT4 and FT3 levels
Thyroid nodule volume
Volume of thyroid nodule assessed by ultrasound
Treatment related adverse events
Number of adverse and serious adverse events
Thyroid related quality of life
Thyroid related quality of life assessed by ThyPro questionnaire
Cost-effectiveness
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
Course of thyroid function
Assessed by TSH, FT4 and FT3 an medication use
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').

Full Information

First Posted
November 5, 2021
Last Updated
April 3, 2023
Sponsor
Rijnstate Hospital
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, University of Twente, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05142904
Brief Title
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Acronym
RABITO
Official Title
Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, University of Twente, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Toxic or With Hyperthyroidism, Autonomous Thyroid Function, Thyroid Nodule; Hyperthyroidism, Radiofrequency Ablation, Iodine Hyperthyroidism, Iodine Adverse Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation
Arm Type
Experimental
Arm Description
Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.
Arm Title
Radioactive iodine, study protocol
Arm Type
Active Comparator
Arm Description
Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
Arm Title
Radioactive iodine, cohort
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Other Intervention Name(s)
RFA, Ultrasound-guided radiofrequency ablation
Intervention Description
Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.
Intervention Type
Drug
Intervention Name(s)
Radioactive iodine
Other Intervention Name(s)
I-131
Intervention Description
I-131 according to standardized doses-calculation.
Intervention Type
Drug
Intervention Name(s)
Radioactive iodine
Other Intervention Name(s)
I-131
Intervention Description
I-131 according to local standard.
Primary Outcome Measure Information:
Title
Hypothyroidism
Description
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
Time Frame
1 year post-intervention
Secondary Outcome Measure Information:
Title
Cure rate
Description
Medication-free normalization of TSH, FT4 and FT3 levels
Time Frame
1 year post-intervention
Title
Thyroid nodule volume
Description
Volume of thyroid nodule assessed by ultrasound
Time Frame
Baseline, 6 and 12 months post-intervention
Title
Treatment related adverse events
Description
Number of adverse and serious adverse events
Time Frame
6 weeks and 3, 6 and 12 months post-intervention
Title
Thyroid related quality of life
Description
Thyroid related quality of life assessed by ThyPro questionnaire
Time Frame
Baseline, 6 and 12 months after intervention
Title
Cost-effectiveness
Description
Determined as the incremental costs in Euros per quality adjusted life year (QALY)
Time Frame
Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention
Title
Course of thyroid function
Description
Assessed by TSH, FT4 and FT3 an medication use
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.
Title
Short-term patient satisfaction
Description
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').
Time Frame
1 week and 1 year post-intervention
Other Pre-specified Outcome Measures:
Title
Health outcomes and quality of life
Description
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)
Time Frame
Baseline, 6 and 12 months after intervention
Title
Use of hospital resources
Description
According to medical records
Time Frame
1 year post-intervention
Title
Medical consumption
Description
iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)
Time Frame
1 year post-intervention
Title
Use of healthcare resources
Description
iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)
Time Frame
1 year post-intervention
Title
Cumulative cost
Description
Based on Rijnstate price estimates
Time Frame
1 year post-intervention
Title
Fractional nodal uptake
Description
Assessed by I-123 or I-131 scintigraphy
Time Frame
1 year post-intervention
Title
Treatment related auto-immunity
Description
Assessed by thyroid antibodies
Time Frame
Baseline and 1 year post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon MD van der Meeren, MD
Phone
088 005 8888
Email
mvandermeeren@rijnstate.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Wim Oyen, Prof.
Phone
088 005 8888
Email
RABITOstudie@rijnstate.nl
Facility Information:
Facility Name
Ziekenhuis Groep Twente
City
Almelo
State/Province
Gelderland
ZIP/Postal Code
7609PP
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sicco Braak
Email
s.braak@zgt.nl
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6815AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon van der Meeren, MD
Phone
088 005 8888
Email
mvandermeeren@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Wim Oyen, Prof.
Phone
088 005 8888
Email
RABITOstudie@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
Wim Oyen, Prof.
First Name & Middle Initial & Last Name & Degree
Frank Joosten, MD, PhD
First Name & Middle Initial & Last Name & Degree
Manon MD van der Meeren, MD
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Krol
Email
CKrol@amphia.nl
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jerome Kisters
Email
jerome.kisters@catharinaziekenhuis.nl
Facility Name
Elkerliek Hospital
City
Helmond
State/Province
Noord-Brabant
ZIP/Postal Code
5707HA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petri Kox
Email
pm.vangastel@elkerliek.nl
Facility Name
Amsterdam UMC, location VUMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pim de Graaf, PhD
Phone
020 444 4444
Email
p.degraaf@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Koen Dreijerink, MD
Phone
020 444 4444
Email
k.dreijerink@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Pim de Graaf, PhD
Facility Name
Albert Schweiter Hospital
City
Dordrecht
State/Province
Zuid Holland
ZIP/Postal Code
3318AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Hartong
Email
s.c.c.hartong@asz.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

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