Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-04-24 @ 6:41 PM
Study NCT ID:
NCT02877602
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2016-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Understanding of LiverMultiScan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-11', 'studyFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors effecting MRI experience and understanding.', 'timeFrame': 'Immediately (within 1 hour) after undergoing the MRI scan, and receiving results feedback.', 'description': 'This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.'}], 'secondaryOutcomes': [{'measure': 'Comparison of MRI to ultrasound scan in terms of patient experience.', 'timeFrame': 'Immediately (within 1 hour) after undergoing an MRI scan, and ultrasound (FibroScan) scan.', 'description': 'This will be analysed based on themes and trends emanating from answers within the focused interview and questionnaire following the scan, and results feedback.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Diseases']}, 'referencesModule': {'references': [{'pmid': '34508298', 'type': 'DERIVED', 'citation': 'McKay A, Pantoja C, Hall R, Matthews S, Spalding P, Banerjee R. Patient understanding and experience of non-invasive imaging diagnostic techniques and the liver patient pathway. J Patient Rep Outcomes. 2021 Sep 10;5(1):89. doi: 10.1186/s41687-021-00363-5.'}]}, 'descriptionModule': {'briefSummary': 'This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them.', 'detailedDescription': 'This is a qualitative study to determine which factors affect the patient experience of having a liver MRI, what information patients would like to receive after their MRI, and how patients would like this information communicated to them. Each individual will receive at least an MRI scan (LiverMultiScan), with many also receiving a FibroScan (Transient Elastography). Patients will then undergo a focused qualitative interview, as well as filling out a questionnaire. The interviews will be thematically analysed and trends identified by significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with experience of liver disease, either as a sufferer or carer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with experience of liver disease.\n* Individuals over the age of 16.\n* Individuals willing to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Individuals with any contraindication to magnetic resonance imaging.'}, 'identificationModule': {'nctId': 'NCT02877602', 'briefTitle': 'Patient Understanding of LiverMultiScan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perspectum'}, 'officialTitle': 'Patient Understanding of LiverMultiScan', 'orgStudyIdInfo': {'id': 'Patient LMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experience of liver disease', 'description': 'This is defined as either those who have had direct experience of liver disease as sufferers, or the carers of those who have had liver disease. Each individual receives an MRI (LiverMultiScan), with many also receiving a FibroScan.', 'interventionNames': ['Device: MRI', 'Device: Transient Elastography']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'otherNames': ['LiverMultiScan'], 'armGroupLabels': ['Experience of liver disease']}, {'name': 'Transient Elastography', 'type': 'DEVICE', 'otherNames': ['FibroScan'], 'armGroupLabels': ['Experience of liver disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Rajarshi Banerjee, BM BCh MRCP MSc DPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Perspectum Diagnostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perspectum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}