Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04137705
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2019-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MultiOrgan Multi-Parametric MRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of the mean differences in body composition and multiple organ metrics between healthy participants and those with type 2 diabetes acquired with multiparametric MRI.', 'timeFrame': '24 months', 'description': 'To determine the range of body composition and multi-organ metrics (liver, pancreas, aorta, heart, kidney, lungs and spleen) in healthy participants and in those with type 2 diabetes assessed using multiparametric MRI.'}], 'primaryOutcomes': [{'measure': 'Assessment of repeatability (precision under the same conditions in the same subjects: 2 separate MRI acquisitions on the same scanner) of body composition and multiple organ metrics.', 'timeFrame': '24 months', 'description': 'To determine the repeatability of multiparametric MRI in the assessment of body composition and multiple organ structures obtained within a single MR scanning session (liver, pancreas, aorta, heart, kidney, lungs and spleen)'}], 'secondaryOutcomes': [{'measure': 'Assessment of the reproducibility (precision under different measurement conditions: same participants scanned on separate MRI scanners at both 1.5T and 3T) of multiparametric MRI for the assessment of body composition and multiple organ metrics.', 'timeFrame': '24 months', 'description': 'To determine the reproducibility of multiparametric MRI in the assessment of body composition and multiple organ structures (liver, pancreas, aorta, heart, kidney, lungs and spleen) obtained within separate MR scanning sessions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'To determine the reproducibility of a single quantitative multiparametric MRI for the assessment of body composition and multiple organ structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult volunteers, including healthy volunteers and individuals with Type 2 Diabetes (T2D).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any person over 18 years of age.\n* Participant is willing and able to give informed consent for participation in the investigation.\n* EITHER: Participant has Type 2 Diabetes OR: Person is a healthy volunteer\n\nExclusion Criteria:\n\n* The participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).\n* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation"}, 'identificationModule': {'nctId': 'NCT04137705', 'acronym': 'MORIS', 'briefTitle': 'MultiOrgan Multi-Parametric MRI Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perspectum'}, 'officialTitle': 'MultiOrgan Multi-Parametric MRI Study', 'orgStudyIdInfo': {'id': 'CA0080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multiparametric MRI', 'type': 'OTHER', 'description': 'A standardised MRI protocol that provides a number of quantitative metrics on liver and other organs relevant to type 2 Diabetes - pancreas, kidneys, spleen, heart, lungs and aorta'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX1 2EH', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Beaver House', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Centre for Magnetic Resonance', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'OX4 2LL', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Gemini One', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Rajarshi Banerjee', 'role': 'STUDY_CHAIR', 'affiliation': 'Perspectum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perspectum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}