{
  "FullStudy":{
    "Rank":217605,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519219",
          "OrgStudyIdInfo":{
            "OrgStudyId":"UMCC 2003.081"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"HUM00041352",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"University of Michigan Medical IRB"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"University of Michigan Rogel Cancer Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation",
          "OfficialTitle":"Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation",
          "Acronym":"IC-Green"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2019",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2003"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"September 23, 2011",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 8, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 9, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Michigan Rogel Cancer Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The goal of the trial is to assess the effect of radiation treatment on liver function as determined by indocyanine green extraction. The long term goal is to determine if individual assessment of liver function using the IC-Green method, either alone or in combination with other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are superior to the probabilistic method currently in use.",
          "DetailedDescription":"Following intravenous injection, IC-GREEN is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). IC-GREEN is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. It undergoes no significant extrahepatic or enterohepatic circulation. Simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Therefore, the serum clearance rate (determined from serial serum concentration measurements at various times after intravenous injection) can serve as a useful index of liver function."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hepatic Irradiation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "hepatic irradiation",
              "IC-GREEN"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"240",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Hepatic Irradiation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Radiation: Hepatic Irradiation"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Radiation",
                "InterventionName":"Hepatic Irradiation",
                "InterventionDescription":"Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Hepatic Irradiation"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Baseline IC-GREEN elimination",
                "PrimaryOutcomeDescription":"Most subjects will have five IC-GREEN assessments. Graphical displays will be used to choose the form of a time-dependent model of IC-GREEN elimination. A mixed, possibly nonlinear model, with patient as random effect, will be fit to the data by the maximum likelihood principle. Profile confidence intervals for the parameters will be determined.",
                "PrimaryOutcomeTimeFrame":"1 day"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in IC-green elimination after radiation therapy",
                "SecondaryOutcomeDescription":"Using model parameters, a cumulative distribution function for IC-GREEN elimination at each time point will be determined from the patients who do not contract RILD. This will result in a smooth estimate of the IC-GREEN assay results, from which lower normal bounds (at, for instance, the fifth percentile) can be established.",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n18 or older, all gender, ethnicities and races\nLife expectancy of at least 12 weeks\nZubrod performance status ≤ 2\nBaseline clinical assessments of liver function by complete history and physical examination\nLaboratory tests to be done within 6 weeks prior to start of radiation: CBC and platelets, liver function tests including SGOT, SGPT, Alkaline Phosphatase, and bilirubin, albumin, BUN, creatinine, PT/PTT, INR\n\nExclusion Criteria:\n\nPregnant\nHistory of allergy or are sensitive to IC-Green, iodine or to radiographic media",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients who take part in this study are required to be scheduled for hepatic irradiation.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Jody Sharp",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"(734) 615-4909",
                "CentralContactEMail":"sharpjd@umich.edu"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dawn Owen, MD",
                "OverallOfficialAffiliation":"University of Michigan Rogel Cancer Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Michigan Comprehensive Cancer Center",
                "LocationStatus":"Recruiting",
                "LocationCity":"Ann Arbor",
                "LocationState":"Michigan",
                "LocationZip":"48109-5010",
                "LocationCountry":"United States",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Cancer AnswerLine",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"800-865-1125",
                      "LocationContactEMail":"canceranswerline@umich.edu"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}