Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-27 @ 2:18 AM
Study NCT ID:
NCT04592393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-18
First Post:
2020-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreas Cancer Surveillance Using an Abbreviated MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2020-10-16', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of performance of abbreviated PB MRI', 'timeFrame': '1 year after the last surveillance MRI.', 'description': 'comparison of the rates of pancreas cancer detection between abbreviated MRI and conventional follow-up methods (in available cases)'}, {'measure': 'Identification of super-high risk group of developing pancreas cancer', 'timeFrame': '1 year after the last surveillance MRI.', 'description': 'Identification of any common radiologic features and gene mutation in participants in whom pancreas cancer develop during the study period.'}], 'primaryOutcomes': [{'measure': 'Detection of pancreas cancer', 'timeFrame': '1 year after the last surveillance MRI.', 'description': 'number of detected pancreas cancer (resectable \\& BRPC only) in surveillance MRI.'}], 'secondaryOutcomes': [{'measure': 'Scan time of abbreviated PB MRI for surveillance', 'timeFrame': '1 month after the first surveillance MRI.', 'description': 'table time, in-room time measurement for feasibility'}, {'measure': 'Estimation of pancreas cancer risk', 'timeFrame': '1 year after the last surveillance MRI.', 'description': 'rate of developing pancreas cancer during the study period'}, {'measure': 'Detection of pancreas cancer', 'timeFrame': '1 year after the last surveillance MRI.', 'description': 'number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pancreas cancer', 'intraductal papillary mucinous neoplasm', 'magnetic resonance imaging'], 'conditions': ['Pancreas Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to establish a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On follow-up due to first degree-family history of PAC\n* Or on follow-up for BD-IPMN (\\>= 2 cm) or main-duct type IPMN (\\> 5 mm)\n* And signed informed consent\n\nExclusion Criteria:\n\n* Contra-indication of performing MRI\n* Not satisfying the selection criteria.\n* Previously diagnosed with pancreatic malignancy\n* Pregnancy or planning pregnancy'}, 'identificationModule': {'nctId': 'NCT04592393', 'briefTitle': 'Pancreas Cancer Surveillance Using an Abbreviated MRI', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'SNUH-2020-2950'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abbreviated PB MRI', 'description': 'Short and Focused non-contrast MRI for surveillance', 'interventionNames': ['Diagnostic Test: Abbreviated PB MRI', 'Genetic: Gene mutation test', 'Diagnostic Test: Conventional follow-up']}], 'interventions': [{'name': 'Abbreviated PB MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Annual non-contrast PB MRI.', 'armGroupLabels': ['Abbreviated PB MRI']}, {'name': 'Gene mutation test', 'type': 'GENETIC', 'description': 'K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.', 'armGroupLabels': ['Abbreviated PB MRI']}, {'name': 'Conventional follow-up', 'type': 'DIAGNOSTIC_TEST', 'description': 'Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.', 'armGroupLabels': ['Abbreviated PB MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Min Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}