Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-02 @ 3:51 AM
Study NCT ID:
NCT05361356
Status:
TERMINATED
Last Update Posted:
2023-04-07
First Post:
2022-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectral CT Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excellent and good rate of clinical imaging (score≥3）', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory'}], 'secondaryOutcomes': [{'measure': 'Common functions assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied'}, {'measure': 'Convenience evaluation assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied'}, {'measure': 'Machine function and stability assessment', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied'}, {'measure': 'Adverse events and serious adverse events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT scanning, image assessment'], 'conditions': ['Adult ALL']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.', 'detailedDescription': 'Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers (ages 18 to 75);\n* Negative pregnancy tests for women of childbearing age;\n* Agree to participate in the clinical trial and sign the subject informed consent form;\n* Enhanced scan requires laboratory evidence of normal renal function.\n\nExclusion Criteria:\n\n* The body cannot comply with CT examination;\n* Pregnant and lactating women;\n* Claustrophobia;\n* People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);\n* Patients deemed unsuitable for participation in this clinical trial by the investigator.'}, 'identificationModule': {'nctId': 'NCT05361356', 'briefTitle': 'Spectral CT Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Philips (China) Investment CO., LTD'}, 'officialTitle': 'Spectral CT Clinical Trial', 'orgStudyIdInfo': {'id': 'PD_CT_Hawk_2021_11257'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group, all volunteer will be scanned.', 'description': 'All participation accept Spectral CT scanning; No group;', 'interventionNames': ['Radiation: Spectral CT scanning']}], 'interventions': [{'name': 'Spectral CT scanning', 'type': 'RADIATION', 'description': 'Volunteer accept spectral CT scanning', 'armGroupLabels': ['Experimental group, all volunteer will be scanned.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': "Xi'an", 'country': 'China', 'facility': 'The First Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Daming Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital'}, {'name': 'Yikai Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}, {'name': 'Ting Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philips (China) Investment CO., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}