Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 1:44 AM
Study NCT ID:
NCT05844332
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2023-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LUTATHERA Injection General Use Result Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C447941', 'term': 'lutetium Lu 177 dotatate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 347}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises', 'timeFrame': 'Until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).', 'description': 'To evaluate the safety about Renal dysfunction, Myelosuppression, Myelodysplastic syndrome/acute myeloid leukaemia and Hormone release induced crises after administration of this drug in a real world setting'}]}, 'conditionsModule': {'keywords': ['LUTATHERA'], 'conditions': ['Somatostatin Receptor-positive Neuroendocrine Tumor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18390', 'label': 'Link to study results'}]}, 'descriptionModule': {'briefSummary': 'This study was a multicenter observational study with a central registration system and all-case surveillance system without a control group.', 'detailedDescription': 'From the date of the first dose of this drug until 40 weeks after the date of the last dose (64 weeks if 4 doses are administered 8 weeks apart).\n\nFor patients who discontinue treatment with this drug during the observation period, necessary variables were examined until 40 weeks after the last dose of this drug during the observation period and recorded in the case report forms (CRF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated with this drug for the following indications during a certain post-marketing period\n\n• Indication: Somatostatin receptor-positive neuroendocrine tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated with this drug for the following indications during a certain post-marketing period\n\n * Indication: Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study. Patients treated with this drug for off-label indication will also be included in this study to register all patients received this drug.\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT05844332', 'briefTitle': 'LUTATHERA Injection General Use Result Survey', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'LUTATHERA Injection General Use Result Survey (Somatostatin Receptor-positive Neuroendocrine Tumor, CAAA601A11401)', 'orgStudyIdInfo': {'id': 'CAAA601A11401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LUTATHERA', 'description': 'patients treated with LUTATHERA Injection', 'interventionNames': ['Other: LUTATHERA']}], 'interventions': [{'name': 'LUTATHERA', 'type': 'OTHER', 'otherNames': ['Lutetium oxodotreotide (177Lu)'], 'description': 'There was no treatment allocation. Patients administered LUTATHERA by prescription could be enrolled.', 'armGroupLabels': ['LUTATHERA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464 8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '036 8563', 'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '296-8602', 'city': 'Kamogawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.0969, 'lon': 140.1003}}, {'zip': '277 8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '7910295', 'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'zip': '910-8526', 'city': 'Fukui-shi', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'zip': '501-1194', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '371 8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '060 8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '608543', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '673-8558', 'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'zip': '6500047', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '920 8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '7610793', 'city': 'Kita-gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '890 8520', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '247-8533', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '236-0004', 'city': 'Yokohama', 'state': 'Kanagawa-ku', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, 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{'zip': '7708503', 'city': 'Tokushima', 'state': 'Tokushima', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '1138519', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '104 0045', 'city': 'Chuo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '135 8550', 'city': 'Koto Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '9300194', 'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'zip': '990 9585', 'city': 'Yamagata', 'state': 'Yamagata', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'zip': '409-3898', 'city': 'Chūō', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 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'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '606 8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '7008558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '5458586', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}