Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT03623360
Status:
UNKNOWN
Last Update Posted:
2018-08-09
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional MRI to Determine Severity of Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality', 'timeFrame': 'Up to 7 days', 'description': 'The image quality evaluated visually by an expert radiologist using a scoring system. The score levels for the image quality assessments is: 1: non-diagnostic, 2: poor, 3: adequate, 4: good, and 5: excellent.'}, {'measure': 'The dynamic range of the Total Blood Flow biomarker.', 'timeFrame': 'Up to 7 days', 'description': 'Calculation of the dynamic range of the Total Blood Flow biomarker (ml/100ml/min).'}, {'measure': 'The dynamic range of the Arterial Blood Flow Fraction biomarker.', 'timeFrame': 'Up to 7 days', 'description': 'Calculation of the dynamic range of the Arterial Blood Flow Fraction biomarker (%)'}, {'measure': 'The dynamic range of the Extracellular Volume biomarker.', 'timeFrame': 'Up to 7 days', 'description': 'Calculation of the dynamic range of the Extracellular Volume biomarker (ml/100ml)'}, {'measure': 'The dynamic range of the Intracellular Uptake Rate biomarker.', 'timeFrame': 'Up to 7 days', 'description': 'Calculation of the dynamic range of the Intracellular Uptake Rate biomarker (/100/min)'}, {'measure': 'The dynamic range of the Biliary Excretion Rate biomarker.', 'timeFrame': 'Up to 7 days', 'description': 'Calculation of the dynamic range of the Biliary Excretion Rate biomarker (/100/min)'}], 'secondaryOutcomes': [{'measure': 'Correlation of DCE-MRI measures with clinical outcomes', 'timeFrame': 'Up to 7 days', 'description': 'The secondary outcome measure is the correlation between our biomarkers and the clinical scores for the prediction of mortality (Child-Pugh score and the Model to End Stage Liver Disease (MELD)).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gadoxetate disodium'], 'conditions': ['Liver Cirrhosis', 'Liver Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.\n\nThe principal objective of this pilot study is to assess liver function and the future risk of complications in patients with cirrhosis, using novel techniques and measures based on free-breathing Dynamic Contrast Enhanced MRI.\n\nSpecifically the investigators will assess:\n\n1. Whether sufficient data can be generated in patients with cirrhosis whilst maintaining image quality, and\n2. The dynamic range of DCE-MRI measures in patients with cirrhosis.\n\nThis pilot study will, if successful, provide sufficient data to support applications for larger studies to evaluate the clinical utility of a DCE-MRI imaging biomarker in patients with cirrhosis.', 'detailedDescription': "This is a pilot study to investigate the feasibility of a novel MRI technique to assess the severity of liver cirrhosis and predict complications based on functionality and perfusion measurements whilst maintaining image quality.\n\nRecruitment:\n\nTwenty (20) patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital will be purposively selected by members of the research team who are also part of the usual care team for these patients in advance of scheduled clinic visits. The selection will be in a way to encompass the full clinical spectrum of liver function within cirrhosis.\n\nScan:\n\nAn intravenous cannula will be inserted to the patient's arm by the radiographer, for the automated administration of contrast agent during the scan. The participant will be asked to remain still on his/her back throughout the duration of the scan.\n\nPatients will undergo a full MRI protocol including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and the novel functional technique.\n\nAfter the scan:\n\nThe participant will not have to attend any extra clinics or scan appointments. The research team (that includes members of the participants ongoing care team) will continue to track the health condition of the participant over a long-term period (5 years) to collect information with regards to clinical events such as hospital admissions, change in treatment, further procedures and death. The clinical follow-up information will be collected as part of routine care through scheduled ongoing outpatient appointments.\n\nThe data acquired during the scans will be analysed using a novel method to quantify liver function and the liver images will be reviewed by an expert radiologist to ensure that the quality of these is sufficient for future clinical application. A cross-sectional data analysis will be performed to identify associations between the functional biomarkers and clinical indices for the assessment of liver fibrosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with cirrhosis who attend the Leeds Liver Unit at St James's University Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with liver cirrhosis using standard methods (liver biochemistry, ultrasound based elastography and liver biopsy).\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy/intolerance to Gadolinium based contrast agents\n* Severe renal impairment\n* Severe respiratory disease\n* Inability to undergone MRI due to the presence of metal or electronic implants affected by the magnetic field.'}, 'identificationModule': {'nctId': 'NCT03623360', 'briefTitle': 'Functional MRI to Determine Severity of Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Prediction of Outcomes in Cirrhosis Using Novel Magnetic Resonance Imaging Biomarkers of Liver Function', 'orgStudyIdInfo': {'id': 'IRAS 224109'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with liver cirrhosis', 'description': 'The cohort includes patients who encompass the full clinical spectrum of liver function within cirrhosis.\n\nThe participants will undergo a full MRI protocol for liver screening including morphological imaging, fibrosis scoring tests based on relaxometry and diffusion maps, and our novel functional technique based on free breathing DCE-MRI.', 'interventionNames': ['Diagnostic Test: Free breathing DCE-MRI']}], 'interventions': [{'name': 'Free breathing DCE-MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Free breathing DCE-MRI', 'armGroupLabels': ['Patients with liver cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS9 7LN', 'city': 'Leeds', 'country': 'United Kingdom', 'contacts': [{'name': 'Ian Rowe, Dr', 'role': 'CONTACT', 'email': 'i.a.c.rowe@leeds.ac.uk', 'phone': '0044 0113 206 5667'}], 'facility': "St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'centralContacts': [{'name': 'Ian Rowe, Dr', 'role': 'CONTACT', 'email': 'i.a.c.rowe@leeds.ac.uk', 'phone': '0044 0113 206 5667'}, {'name': 'Steven Sourbron, Dr', 'role': 'CONTACT', 'email': 's.sourbron@leeds.ac.uk', 'phone': '0044 0113 343 6063'}], 'overallOfficials': [{'name': 'Ian Rowe, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The information about the health and care of the participants may be provided to researchers running other research studies in this organisation and in other organisations. The information will only be used by organisations and researchers to conduct research in accordance with the United Kingdom Policy Framework for Health and Social Care Research. This information will not identify the individuals and will not be combined with other information in a way that could identify the participants.\n\nThe images obtained from the MRI scan may also be shared anonymously with Siemens, Inc - the company who have developed the techniques to allow scans to be done without breath holding. These images may be used to improve the way that the scans are processed as well as in illustrations of the quality of the images that can be obtained using this technique.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Leeds Academic Fellow and Honorary Consultant Hepatologist', 'investigatorFullName': 'Ian Rowe', 'investigatorAffiliation': 'University of Leeds'}}}}