Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT05428358
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2022-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-08', 'size': 353067, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-06T16:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in treatment strategy', 'timeFrame': '1 week', 'description': 'Change in treatment strategy from intended curative resection to other treatment based on MRI scan'}], 'secondaryOutcomes': [{'measure': 'Liver metastases', 'timeFrame': '1 week', 'description': 'Proportion of patients who had liver metastases detected on MRI'}, {'measure': 'Surgery', 'timeFrame': '1 month', 'description': 'Proportion of patients who made it to surgery/exploration'}, {'measure': 'Resection', 'timeFrame': '1 month', 'description': 'Proportion of patients in each arm who had a pancreatic resection performed'}, {'measure': 'Intraoperatively detected liver metastases', 'timeFrame': '1 month', 'description': 'Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI.'}, {'measure': 'Overall survival (1-year)', 'timeFrame': '1 year', 'description': '1-year overall survival.'}, {'measure': 'Overall survival (3-year)', 'timeFrame': '3 years', 'description': '3-year overall survival.'}, {'measure': 'Recurrence-free survival', 'timeFrame': '3 years', 'description': 'Recurrence-free survival according to final treatment strategy.'}, {'measure': 'Healthcare costs', 'timeFrame': '3 years', 'description': 'Healthcare costs in patients with change of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['magnetic resonance imaging'], 'conditions': ['Pancreatic Cancer', 'Pancreatic Neoplasm', 'Liver Metastases']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.', 'detailedDescription': 'The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients. We will conduct a nationwide, prospective clinical trial to examine the incremental value of using MRI for identification of liver metastases in pancreatic cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Pancreatic cancer patients considered to have a locally resectable or borderline resectable tumor by the local hepato-pancreato-biliary multidisciplinary team board\n* No liver metastases on CT\n* At least 18 years old and able to provide informed consent\n* Expected pancreatic ductal adenocarcinoma based on CT scan\n\nExclusion criteria:\n\n* Metastatic disease\n* Prior receipt of neoadjuvant chemotherapy or downstaging/-sizing treatment\n* Comorbidity rendering major surgery unfeasible (inoperable)\n* No informed consent\n* Unable to undergo MRI (Kidney insufficiency (eGFR \\< 60 ml/min/1.73 m2 body surface ar-ea); Claustrophobia; Cardiac pacemaker)\n* Postoperative histology other than adenocarcinoma of pancreato-biliary origin.\n* MRI with liver-specific contrast performed during standard workup.'}, 'identificationModule': {'nctId': 'NCT05428358', 'acronym': 'MAGIPAC', 'briefTitle': 'Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for Surgery (MAGIPAC): A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'MAGIPAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative MRI', 'description': 'MRI before surgery.', 'interventionNames': ['Diagnostic Test: Preoperative MRI']}], 'interventions': [{'name': 'Preoperative MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection', 'armGroupLabels': ['Preoperative MRI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mogens Stender, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jakob Kirkegård, MD, PhD', 'role': 'CONTACT', 'email': 'jakob.kirkegaard@auh.rm.dk', 'phone': '+4522900604'}, {'name': 'Frank V Mortensen, MD, DMSc', 'role': 'CONTACT', 'email': 'frmort@rm.dk', 'phone': '+45222517296'}, {'name': 'Jakob Kirkegård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Frank V Mortensen, MD, DMSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Carsten P Hansen, MD, DMSc', 'role': 'CONTACT'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Jakob Kirkegård, MD, PhD', 'role': 'CONTACT', 'email': 'jakob.kirkegaard@auh.rm.dk', 'phone': '+4522900604'}, {'name': 'Frank Mortensen, MD, DMSc', 'role': 'CONTACT', 'email': 'frmort@rm.dk', 'phone': '+45222517296'}], 'overallOfficials': [{'name': 'Frank Mortensen, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Jakob Kirkegård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to Danish law, no individual-level data can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}