Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-27 @ 10:41 PM
Study NCT ID:
NCT05111795
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2021-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Holmium-166 Retrospective Collection of Real-World Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and Severity of Adverse Events', 'timeFrame': '30 months', 'description': 'The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '30 months', 'description': 'Time from SIRT procedure until overall progression or death'}, {'measure': 'Hepatic Progression Free Survival (HPFS)', 'timeFrame': '30 months', 'description': 'Time from SIRT procedure until progression in the liver or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': '30 months', 'description': 'Time from SIRT procedure until death from any cause'}, {'measure': 'Tumor response in the liver', 'timeFrame': '3 months', 'description': 'Response as per routine practice following the guidelines for corresponding tumor type'}, {'measure': 'Lung shunt prediction', 'timeFrame': '1 month', 'description': 'Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose'}], 'secondaryOutcomes': [{'measure': 'Administered activity', 'timeFrame': '1 month', 'description': 'The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.'}, {'measure': 'Liver volume treated', 'timeFrame': '1 month', 'description': 'The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.'}, {'measure': 'SIRT treatment approach', 'timeFrame': '1 month', 'description': 'The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.'}, {'measure': 'Tumor absorbed dose', 'timeFrame': '1 month', 'description': 'The technical performance of SIRT in term of tumor absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.'}, {'measure': 'Normal liver absorbed dose', 'timeFrame': '1 month', 'description': 'The technical performance of SIRT in term of normal liver absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.'}, {'measure': 'The use of Q-SuiteTM in clinical practice', 'timeFrame': '1 month', 'description': "The use of Q-SuiteTM in clinical practice will be recorded based on the software which is mentioned in the description of treatment or the presence of a Q-SuiteTM generated report in the patient's medical file."}, {'measure': 'Number of patients downstaged to liver resection or liver transplantation', 'timeFrame': '30 months', 'description': 'The number of patients downstaged to liver resection or liver transplantation will be reviewed based on the number of patients that underwent liver resection or liver transplantation after the SIRT procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.', 'detailedDescription': 'This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population to be included has been treated at the top-ordering hospitals for QuiremSpheresTM Holmium-166 Microspheres. All patients treated at these hospitals between 15 July 2019 and 15 July 2021 are aimed to be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with diagnosis of primary liver tumor or metastases in the liver.\n* Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.\n* Patient is ≥ 18 years.\n* If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.\n\nExclusion Criteria:\n\n* Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.'}, 'identificationModule': {'nctId': 'NCT05111795', 'acronym': 'RECORD', 'briefTitle': 'Holmium-166 Retrospective Collection of Real-World Data', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo Europe N.V.'}, 'officialTitle': 'Holmium-166 Retrospective Collection of Real-World Data', 'orgStudyIdInfo': {'id': 'T141E4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres', 'type': 'DEVICE', 'otherNames': ['SIRT, Radioembolization, TARE'], 'description': 'SIRT work-up procedure and SIRT procedure'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'ASZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'CUB Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Herford', 'country': 'Germany', 'facility': 'Klinikum Herford', 'geoPoint': {'lat': 52.11457, 'lon': 8.67343}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'IFO IRCCS - Istituto Nazionale Tumori Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Instituto Português De Oncologia Do Porto Francisco Gentil, EPE', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo Europe N.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}