Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-03 @ 2:21 AM
Study NCT ID:
NCT02618460
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2015-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal NCE-MRI in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2015-11-26', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparent Diffusion Coefficient (ADC)', 'timeFrame': 'At baseline.', 'description': 'Renal perfusion and diffusion parameter assessed by Diffusion Weighted Imaging (DWI) MRI, characterising normal physiology.'}, {'measure': 'T2*', 'timeFrame': 'At baseline.', 'description': 'Renal blood oxygenation parameter assessed by Blood Oxygenation Level Dependent (BOLD) MRI, characterising normal physiology.'}, {'measure': 'Renal artery flow.', 'timeFrame': 'At baseline.', 'description': 'Renal perfusion parameter assessed by Phase-Contrast (PC) MRI, characterising normal physiology.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-contrast enhanced MRI', 'healthy volunteers', 'renal diffusion', 'renal perfusion'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Non-contrast enhanced (NCE) structural MRI enables to investigate renal anatomy.\n\nAdditional NCE-MR acquisition modalities (e.g. Diffusion Weighted Imaging (DWI), Blood Oxygenation Level Dependent (BOLD) MRI, Arterial Spin Labeling (ASL), MR Angiography (MRA), phase-contrast MRI), which could be used in combination with structural MRI in a single acquisition session, have been identified to investigate in more detail renal function and structure, opening the possibility to estimate local renal diffusion and blood perfusion, beyond providing high-resolution anatomical accuracy.\n\nPreliminary to the identification of novel imaging biomarkers of renal disease progression, perfusion and diffusion MR sequences need to be optimized for the renal compartment. Moreover, NCE-MRIs acquired on healthy volunteers are required to investigate perfusion and diffusion changes in pathological kidneys as compared to normal and physiological condition.\n\nThe objective of this study is to provide normal control NCE-MRI sequences to be used as reference for the investigation of perfusion and diffusion changes in the kidney of patients affected by chronic kidney disease (e.g. diabetic nephropathy, nephrosclerosis, autosomal dominant polycystic kidney disease).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 and ≤59 years ;\n* Healthy volunteers;\n* Written informed consent.\n\nExclusion Criteria:\n\n* Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment;\n* Pregnancy (due to safety reasons).'}, 'identificationModule': {'nctId': 'NCT02618460', 'briefTitle': 'Renal NCE-MRI in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': 'Non-contrast Enhanced MR Imaging of the Kidney in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Renal NCE-MRI in volunteers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Group', 'interventionNames': ['Device: Non contrast-enhanced magnetic resonance imaging']}], 'interventions': [{'name': 'Non contrast-enhanced magnetic resonance imaging', 'type': 'DEVICE', 'armGroupLabels': ['Whole Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'state': 'Bergamo', 'country': 'Italy', 'facility': 'Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'EC-DG Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}