Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-27 @ 1:30 PM
Study NCT ID:
NCT05142904
Status:
TERMINATED
Last Update Posted:
2025-07-17
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}, {'id': 'C000614965', 'term': 'Iodine-131'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Switched from RCT to observational prospective cohort due to termination of subsidy (delay due to insufficient inclusion-rate). Follow-up of RCT-arm will be completed. Patients can still be included in a observational cohort.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health outcomes and quality of life', 'timeFrame': 'Baseline, 6 and 12 months after intervention', '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)'}, {'measure': 'Use of hospital resources', 'timeFrame': '1 year post-intervention', 'description': 'According to medical records'}, {'measure': 'Medical consumption', 'timeFrame': '1 year post-intervention', 'description': 'iMCQuestionnaire (institute for medical technology assessment medical consumption questionnaire)'}, {'measure': 'Use of healthcare resources', 'timeFrame': '1 year post-intervention', 'description': 'iPCQuestionnaire (institute for medical technology assessment productivity cost questionnaire)'}, {'measure': 'Cumulative cost', 'timeFrame': '1 year post-intervention', 'description': 'Based on Rijnstate price estimates'}, {'measure': 'Fractional nodal uptake', 'timeFrame': '1 year post-intervention', 'description': 'Assessed by I-123 or I-131 scintigraphy'}, {'measure': 'Treatment related auto-immunity', 'timeFrame': 'Baseline and 1 year post-intervention', 'description': 'Assessed by thyroid antibodies'}], 'primaryOutcomes': [{'measure': 'Hypothyroidism', 'timeFrame': '1 year post-intervention', 'description': 'Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)'}], 'secondaryOutcomes': [{'measure': 'Cure rate', 'timeFrame': '1 year post-intervention', 'description': 'Medication-free normalization of TSH, FT4 and FT3 levels'}, {'measure': 'Thyroid nodule volume', 'timeFrame': 'Baseline, 6 and 12 months post-intervention', 'description': 'Volume of thyroid nodule assessed by ultrasound'}, {'measure': 'Treatment related adverse events', 'timeFrame': '6 weeks and 3, 6 and 12 months post-intervention', 'description': 'Number of adverse and serious adverse events'}, {'measure': 'Thyroid related quality of life', 'timeFrame': 'Baseline, 6 and 12 months after intervention', 'description': 'Thyroid related quality of life assessed by ThyPro questionnaire'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention', 'description': 'Determined as the incremental costs in Euros per quality adjusted life year (QALY)'}, {'measure': 'Course of thyroid function', 'timeFrame': 'Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.', 'description': 'Assessed by TSH, FT4 and FT3 an medication use'}, {'measure': 'Short-term patient satisfaction', 'timeFrame': '1 week and 1 year post-intervention', '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')."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodule, Toxic or With Hyperthyroidism', 'Autonomous Thyroid Function', 'Thyroid Nodule; Hyperthyroidism', 'Radiofrequency Ablation', 'Iodine Hyperthyroidism', 'Iodine Adverse Reaction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* 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:\n\n * Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels\n * Anti-TSH antibody negative\n * 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.\n* Treatment with RAI indicated, and eligible for RFA treatment\n* Signed informed consent Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group.\n\nExclusion Criteria:\n\n* Multifocal HTN\n* HTN \\> 50 mm\n* Presence of a medical device susceptible to disturbances caused by RFA generated currents\n* Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local anesthesia\n* Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility\n* Uncorrectable haemorrhagic diathesis\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05142904', 'acronym': 'RABITO', 'briefTitle': 'Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules', 'orgStudyIdInfo': {'id': '2021-1798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency ablation', 'description': 'Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.', 'interventionNames': ['Device: Radiofrequency ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Radioactive iodine, study protocol', 'description': 'Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.', 'interventionNames': ['Drug: Radioactive iodine']}, {'type': 'OTHER', 'label': 'Radioactive iodine, cohort', '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).', 'interventionNames': ['Drug: Radioactive iodine']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'DEVICE', 'otherNames': ['RFA', 'Ultrasound-guided radiofrequency ablation'], 'description': 'Ultrasound-guided radiofrequency ablation of the solitary autonomous thyroid nodule.', 'armGroupLabels': ['Radiofrequency ablation']}, {'name': 'Radioactive iodine', 'type': 'DRUG', 'otherNames': ['I-131'], 'description': 'I-131 according to standardized doses-calculation.', 'armGroupLabels': ['Radioactive iodine, study protocol']}, {'name': 'Radioactive iodine', 'type': 'DRUG', 'otherNames': ['I-131'], 'description': 'I-131 according to local standard.', 'armGroupLabels': ['Radioactive iodine, cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7609PP', 'city': 'Almelo', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Ziekenhuis Groep Twente'}, {'zip': '7334DZ', 'city': 'Apeldoorn', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Gelre Hospitals', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '6815AD', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '6043CV', 'city': 'Roermond', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Laurentius Hospital', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'zip': '4818', 'city': 'Breda', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '5623EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '5707HA', 'city': 'Helmond', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Elkerliek Hospital', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'zip': '1081HV', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location VUMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091AC', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2134 TM Hoofddorp', 'city': 'Hoofddorp', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Spaarne Gasthuis', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '3318AT', 'city': 'Dordrecht', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Albert Schweiter Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '2512VA', 'city': 'The Hague', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Haaglanden MC', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '2725 NA', 'city': 'Zoetermeer', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Haga Ziekenhuizen', 'geoPoint': {'lat': 52.0575, 'lon': 4.49306}}, {'zip': '9728 NT Groningen', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Martini Hospital', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'University of Twente', 'class': 'OTHER'}, {'name': 'Amsterdam UMC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}