{
  "FullStudy":{
    "Rank":217786,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516853",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011-0473"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2011-0473",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Institutional Review Board"
              },{
                "SecondaryId":"A539300",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"UW Madison"
              },{
                "SecondaryId":"SMPH\\RADIOLOGY\\RADIOLOGY",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"UW Madison"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"University of Wisconsin, Madison",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Non-invasive Quantification of Liver Iron With MRI",
          "OfficialTitle":"Non-invasive Quantification of Liver Iron With MRI"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"August 17, 2011",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 4, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 6, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Wisconsin, Madison",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No",
          "IsFDARegulatedDrug":"No",
          "IsFDARegulatedDevice":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic, specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis, quantitative staging and treatment monitoring or hepatic iron overload.",
          "DetailedDescription":"Excessive accumulation of iron in the body can result from abnormal intestinal absorption in hereditary hemochromatosis or repeated intravenous blood transfusions (ie: transfusional hemosiderosis). Excess body iron is highly toxic, and requires treatment aimed at reducing body iron stores. Measurement of body iron stores is critical for detection of iron overload, staging its severity and monitoring of iron-reducing therapies that are often extremely expensive (>$40,000/year) and carry their own toxicities. MRI has been shown to be very sensitive to the presence of iron. The investigators have developed an MRI-based method for rapid iron quantification (for instance, whole liver in a single breath-hold). The purpose of this work is to validate this new method using the FDA-approved Ferriscan technique (Resonance Health, Claremont, Australia) as a reference standard."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Iron Overload",
              "Hemosiderosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Patient Group",
                "ArmGroupDescription":"Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Non-contrast MRI"
                  ]
                }
              },{
                "ArmGroupLabel":"Control Group",
                "ArmGroupDescription":"Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Non-contrast MRI"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Non-contrast MRI",
                "InterventionDescription":"Non-contrast MRI will be performed on each subject, at both 1.5T and 3.0T. Different MRI sequences (spin-echo and gradient-echo) will be used, with varying acquisition parameters (e.g., echo times, spatial resolution).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control Group",
                    "Patient Group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Calibration Curve of Liver R2* vs. HIC Measured by FerriScan",
                "PrimaryOutcomeDescription":"Accuracy of non-contrast R2*-MRI for measuring hepatic iron concentration.",
                "PrimaryOutcomeTimeFrame":"Up to 1 day"
              },{
                "PrimaryOutcomeMeasure":"Correlation of Ferritin and Liver R2*",
                "PrimaryOutcomeDescription":"Linear correlation between serum ferritin values and MRI R2* values",
                "PrimaryOutcomeTimeFrame":"up to 1 day"
              },{
                "PrimaryOutcomeMeasure":"Correlation of Ferritin and HIC Measured by FerriScan",
                "PrimaryOutcomeDescription":"Linear correlation between serum ferritin values and FerriScan hepatic iron measurement.",
                "PrimaryOutcomeTimeFrame":"up to 1 day"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Variability of cardiac R2* with different imaging parameters",
                "SecondaryOutcomeDescription":"Robustness of Proposed Method for Cardiac R2* Estimation. Measure variability of cardiac R2* with different imaging parameters.",
                "SecondaryOutcomeTimeFrame":"up to 1 day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nControls: 18 years or older with no known history of iron overload or liver disease.\nPatients: 10 years or older with known or suspected iron overload\n\nExclusion Criteria:\n\nPatients with contraindications to MRI (eg. pacemaker, contraindicated metallic implants, claustrophobia, etc) and pregnant females (as determined by self-report during MRI safety screening) will be excluded.\nFor control subjects, those with known liver disease will be excluded.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"10 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Participants with known or suspected iron overload are identified and recruited in 3 different ways, 1) referral from the Division of Hematology/Oncology and Pediatric Hematology/Oncology, 2) via clinical reading of abdominal MRIs for evidence of iron overload, and 3) participants identified to have serum ferritin levels >500 by UW Hospital Clinical Laboratory will be invited to participant. Controls were recruited from a recruitment database.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Scott B Reeder, MD, PhD",
                "OverallOfficialAffiliation":"University of Wisconsin, Madison",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Wisconsin Institutes for Medical Research",
                "LocationCity":"Madison",
                "LocationState":"Wisconsin",
                "LocationZip":"53705",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23801540",
                "ReferenceType":"result",
                "ReferenceCitation":"Hernando D, Cook RJ, Diamond C, Reeder SB. Magnetic susceptibility as a B0 field strength independent MRI biomarker of liver iron overload. Magn Reson Med. 2013 Sep;70(3):648-56. doi: 10.1002/mrm.24848. Epub 2013 Jun 25."
              },{
                "ReferencePMID":"25199788",
                "ReferenceType":"result",
                "ReferenceCitation":"Sharma SD, Hernando D, Horng DE, Reeder SB. Quantitative susceptibility mapping in the abdomen as an imaging biomarker of hepatic iron overload. Magn Reson Med. 2015 Sep;74(3):673-83. doi: 10.1002/mrm.25448. Epub 2014 Sep 8."
              },{
                "ReferencePMID":"27405703",
                "ReferenceType":"result",
                "ReferenceCitation":"Horng DE, Hernando D, Reeder SB. Quantification of liver fat in the presence of iron overload. J Magn Reson Imaging. 2017 Feb;45(2):428-439. doi: 10.1002/jmri.25382. Epub 2016 Jul 13."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000019190",
                "ConditionMeshTerm":"Iron Overload"
              },{
                "ConditionMeshId":"D000006486",
                "ConditionMeshTerm":"Hemosiderosis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019189",
                "ConditionAncestorTerm":"Iron Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M19762",
                "ConditionBrowseLeafName":"Iron Overload",
                "ConditionBrowseLeafAsFound":"Iron Overload",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8155",
                "ConditionBrowseLeafName":"Hemosiderosis",
                "ConditionBrowseLeafAsFound":"Hemosiderosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19761",
                "ConditionBrowseLeafName":"Iron Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T2728",
                "ConditionBrowseLeafName":"Hemosiderosis",
                "ConditionBrowseLeafAsFound":"Hemosiderosis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}