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    Summary
    EudraCT Number:2021-001941-11
    Sponsor's Protocol Code Number:2021-1798
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-09-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001941-11
    A.3Full title of the trial
    Ultrasound-guided radiofrequency ablation versus radioactive iodine as treatment for hyperthyroidism caused by solitary autonomous thyroid nodules.
    Echogeleide radiofrequentie ablatie versus radioactief jodium als behandeling voor hyperthyreoïdie veroorzaakt door solitaire autonome schildkliernoduli.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radiofrequency ablation versus radioactive iodine as treatment for thyroid lumps that produce too much thyroid hormones.
    Radiofrequente ablatie versus radioactief jodium als behandeling van schildklierknobbels die te veel schildklierhormoon maken.
    A.3.2Name or abbreviated title of the trial where available
    RABITO study
    RABITO studie
    A.4.1Sponsor's protocol code number2021-1798
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRijnstate hospital
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMw
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMML medical
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRijnstate hospital
    B.5.2Functional name of contact pointStudy team e-mail
    B.5.3 Address:
    B.5.3.1Street Addresswagnerlaan 55
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6815 AD
    B.5.3.4CountryNetherlands
    B.5.6E-mailRABITOstudie@rijnstate.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sodium Iodide (I-131) Capsules T, capsules 37-7400 MBq/st
    D.2.1.1.2Name of the Marketing Authorisation holderCurium Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients > 18 years with (subclinical) hyperthyroidism caused by a solitary hyperactive thyroid nodules, either as a solitary hyperactive node in an otherwise normal thyroid gland or as a single hyperactive node in a multinodular goiter.
    Patienten >18 jaar met (subklinische) hyperthyreoïdie veroorzaakt door een solitaire hyperactieve schildkliernodus, danwel als een solitaire hyperactieve nodus in een overigens normale schildklier, danwel als een enkele hyperactieve nodus in een multinodulair struma.
    E.1.1.1Medical condition in easily understood language
    Adult patients with a thyroid lump producing too much thyroid hormone.
    Volwassen patiënten met een schildklierknobbel die te veel schildklierhormoon produceert.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10043753
    E.1.2Term Thyroid nodule (toxic)
    E.1.2System Organ Class 100000004860
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10043791
    E.1.2Term Thyrotoxicosis from ectopic thyroid nodule
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess and compare the one year incidence of irreversible hypothyroidism of radioactive iodine (RAI) and radiofrequency ablation (RFA).
    Beoordelen en vergelijken van de 1-jaars incidentie van irreversibele hypothyreoïdie na RAI en RFA.
    E.2.2Secondary objectives of the trial
    - To compare the one-year outcome of RFA or RAI treatment with respect to cure rate, nodal volume reduction, fractional nodal uptake, adverse effects, (thyroid function related) quality of life (QoL), and costs.
    - To assess whether RFA is cost-effective compared to RAI one year after treatment, based on collected data, and over a 10-year time horizon using a health economic state transition model.
    - To assess course of thyroid function and comparison of results of RFA and RAI treatment during a follow-up of 5 years.
    - To assess patient experiences en preferences in both RFA and RAI treatment.
    - To compare outcomes of local standard practices of RAI treatment with nationally standardized RAI treatment.
    - To identify facilitators and barriers for implementation of the treatment RFA or RAI in daily clinical practice beyond the controlled trial setting.
    - To assess treatment related thyroiditis.
    - Vergelijken 1-jaars resultaten van RFA en RAI behandeling in de zin van, genezingspercentage, afname van nodus volume, fractionele nodus uptake, adverse effects, (schildklier gerelateerde) kwaliteit van leven en kosten.
    - Beoordelen of RFA kosteneffectief is ten opzicht van RAI 1 jaar na behandeling gebaseerd op verzamelde data en over een 10-jaars horizon door middel van een gezondheidseconomisch transitie model
    - Om het beloop van de schildklierfunctie van RFA en RAI te vergelijking in een 5-jaars follow-up
    - Om patiënten ervaringen en voorkeuren te beoordelen voor RFA en RAI
    - Om lokale procedures van RAI te vergelijken met een gestandaardiseerde RAI behandeling
    - Het identificeren van voorwaarden en blokkades voor implementatie van RFA en RAI behandeling in de dagelijkse setting, buiten die van een gecontroleerde studiesetting
    - Behandeling gerelateerde thyreoïditis beoordelen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Evaluation of clinical outcome related to dose calculation procedures for RAI treatment of solitary autonomous thyroid nodules. Patients who are not randomized will be treated according to local protocol, which is radioactive iodine. Dosage calculation protocols for radioactive iodine vary between hospitals in the Netherlands. Patients will be asked to complete the same follow-up as the randomized patients, the same data will be collected. Written and oral informed consent will be performed. Data from the RAI group in the RCT will be compared to data from this RAI group.
    Evaluatie van klinische uitkomsten gerelateerd aan dosisberekeningen voor radioactief jodium (RAJ) behandeling van solitaire autonome schildkliernoduli. Patiënten die niet gerandomiseerd worden, worden behandeld volgens lokaal protocol, wat veelal radioactief jodium is. Dosisberekening protocollen voor radioactief jodium variëren in Nederlandse ziekenhuizen. Patiënten in deze groep worden gevraagd om dezelfde follow-up te ondergaan als de gerandomiseerde patiënten, dezelfde data zal worden verzameld. Mondelinge en geschreven informed consent zal worden afgenomen. Data van de RAJ in de RCT groep zal vergeleken worden met de data van deze RAJ groep.
    E.3Principal inclusion criteria
    - Age > 18 years
    - (Subclinical) Hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG)
    - Treatment with RAI indicated and eligible for RFA
    - Signed informed consent
    - Leeftijd >18 jaar
    - (subklinische) hyperthyreoïdie veroorzaakt door een solitaire hyperactieve schildkliernodus (HSN), danwel gelokaliseerd in een overigens normale schildklier, danwel één HSN in een multinodulair struma (MNS)
    - Behandeling met RAI geïndiceerd en geschikt voor FA
    - Ondertekend informed consent
    E.4Principal exclusion criteria
    - Multifocal HTN
    - HTN >50mm
    - Presence of a medical device susceptible to disturbances caused by RFA generated currents
    - Inability to complete RAI treatment (e.g. stay in ssafe isolation protection room) or RFA treatment under local anesthesia
    - Uncorrectable hemorrhagic diathesis
    - Pregnancy
    - Multifocale HSN
    - HSN >50mm
    - Aanwezigheid van een medisch hulpmiddel vatbaar voor interactie veroorzaakt door RFA gegenereerde stromingen
    - Onvermorgen om RAI behandeling (bijv. verblijf in isolatie beschermingskamer) of RFA behandeling onder lokale anesthesie te ondergaan
    - Oncorrigeerbare hemorrhagische diathese
    - Zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    Hypothyroidism, measured by TSH, FT4, FT3
    Hypothyreoïdie, bepaald door TSH, FT4, FT3
    E.5.1.1Timepoint(s) of evaluation of this end point
    one year after treatment
    een jaar na behandeling
    E.5.2Secondary end point(s)
    - Cure rate 1 year after treatment, complete cure is defined as a normalization of TSH, FT4 and FT3 levels without use of thyroid medication
    - Thyroid nodule volume assessed by ultrasound
    - Fractional nodal uptake assessed by I-123 scintigraphy
    - Thyroid antibodies
    - Treatment related adverse events, number of adverse and serious adverse events
    - Thyroid related quality of life, assessed by ThyPro questionnaire
    - Health outcomes and quality of life, based on the European QoL-5 Dimensions (EQ-5D-5L) questionnaire
    - Use of health care resources, according to medical records, iMCQ and iPCQ.
    - Cumulative costs
    - Cost-effectiveness is determined as the incremental costs in Euros per quality adjusted life year (QALY), assessed by the European QoL-5 Dimensions (EQ-5D-5L) and use of health care resources
    - Course of thyroid function as assessed by TSH, FT4 and FT3
    - Short-term patient satisfaction assessed by interviews, a satisfaction questionnaire, pain scoring by visual analog scale (VAS).
    - Genezingspercentage 1 jaar na behandeling gedefinieerd als normalisatie van TSH, FT4 en FT3 zonder schildkliermedicatie gebruik
    - Schildkliernodus volume beoordeeld door echografie
    - Fractionele nodale uptake beoordeeld door scintigrafie
    - Schildklier antistoffen
    - Behandeling gerelateerde adverse events, aantal en ernst
    - Schildklier gerelateerde kwaliteit van leven, beoordeeld door een ThyPro vragenlijst
    - Gezondheidsuitkomsten en kwaliteit van leven, beoordeeld door de EQ-5D-5L vragenlijst
    - Gebruik van gezondheidsmiddelen, beoordeeld uit patiëntendossier, iMCQ en iPCQ
    - Cummulatieve kosten
    - Kosten effectiviteit is bepaald als de oplopende kosten in euros per QALY, beoordeeld middels de EQ-5D-5L en gebruik van gezondheidsmiddelen
    - Beloop van schildklierfunctie dmv THS, Ft4 en FT3
    - Korte termijn patiënten tevredenheid beoordeeld door interviews, tevredenheids vragenlijst en pijnscore
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment follow-up is performed according to current protocol:
    - Thyroid hormones at baseline, 2 and 6 weeks and 3, 6, 9 and 12 months.
    - Ultrasound at baseline, 6 months and 12 months
    - Thyroid antibodies at baseline and 12 months
    - Fractional nodal uptake by I123 scintigraphy at baseline and 12 months

    Patient performed:
    - ThyPro and EQ-5D-5L questionaires at baseline, 6 weeks and 6, 9 and 12 months
    - iMCQ,d IPCQ at 6 weeks, 6 months and 12 months

    Others
    - Adverse events will be monitored continuosly
    - Costeffectiveness will be determined at 1 year
    - Interviews will be performed with a small number of selected patients and health care professionals
    Follow-up van behandeling geschied volgens huidig standaard:
    - Schildklierhomonen op baseline, 2 en 6 weken en 3, 6, 9 en 12 maanden
    - Schildklierecho op baseline, 6 en 12 maanden
    - Schildklierantistoffen op baseline en na 12 maanden
    - Fractionele nodale uptake door middel van I123 scintigrafie op baseline en na 12 maanden

    Patiënt gerelateerd:
    - ThyPro en EQ-5D-5L vragenlijsten op baseline, 6 weken en 6, 9 en 12 maanden
    - iMCQ en iPCQ op 6 weken, 6 en 12 maanden

    Overig:
    - Adverse events worden continu gemonitord
    - Kosteneffectiviteit wordt na 1 jaar bepaald
    - Interviews zullen met een select aantal patiënten en zorgmedewerkers worden afgenomen.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    RFA (dit zal de interventie zijn, RAJ is de comparator)
    RFA (this will be the intervention, RAI is the comparator)
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Laatste bezoek laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state232
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    Geen.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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