{
  "FullStudy":{
    "Rank":217958,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514617",
          "OrgStudyIdInfo":{
            "OrgStudyId":"S53666"
          },
          "Organization":{
            "OrgFullName":"Universitaire Ziekenhuizen Leuven",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization",
          "OfficialTitle":"Diffusion -and Perfusion Weighted MRI for Response Prediction of Symptomatic Leiomyomas Following Uterine Artery Embolization"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2011",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2015",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2016",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"October 28, 2011",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 1, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 2, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Universitaire Ziekenhuizen Leuven",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"It is known that volumetric response of leiomyomas following uterine artery embolization correlates well with patients clinical outcome. The aim of this study is to assess diffusion -and perfusion weighted MRI for the prediction of volumetric response following uterine artery embolization in patients with symptomatic leiomyomas."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Leiomyomas"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Leiomyoma",
              "Diffusion weighted MRI",
              "Perfusion MRI",
              "Uterine artery embolization",
              "Volumetric Response",
              "Women with symptomatic leiomyomas"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Diffusion -and perfusion weighted MRI including iv contrast agent injection",
                "InterventionDescription":"MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patients before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for reason not eligible for the study.\n\nDuring the MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.",
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Dotarem"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Diffusion -and perfusion weighted MRI as a predictor for volumetric response of leiomyomas after uterine artery embolization",
                "PrimaryOutcomeDescription":"Patients will be scanned before (baseline) and after (the day of embolization, 3 days and 3 months after embolization). Measurements of signal intensity (SI) will be performed placing ROIs in the central portion of the lesion avoiding areas of artifact. Apparent diffusion coefficients (ADCs) will be calculated at different time points (before and after embolization). Signal intensity measurements on the dynamic contrast enhanced imaging data sets will be performed.",
                "PrimaryOutcomeTimeFrame":"Participants will be followed for the duration of hospital stay (an expected average of 3 days) and will be systematically followed during their follow-up."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nwomen with symptomatic leiomyomas\n\nExclusion Criteria:\n\nwomen with known contra-indications for MRI (cardiac pacemaker, cochlear implants, claustrophobic patients)\nwomen with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Geert Maleux, MD, Prof.",
                "OverallOfficialAffiliation":"University Hospital Gasthuisberg, department of Interventional Radiology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Radiology Department",
                "LocationCity":"Leuven",
                "LocationZip":"3000",
                "LocationCountry":"Belgium"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007889",
                "ConditionMeshTerm":"Leiomyoma"
              },{
                "ConditionMeshId":"D000047708",
                "ConditionMeshTerm":"Myofibroma"
              },{
                "ConditionMeshId":"D000001835",
                "ConditionMeshTerm":"Body Weight"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000009379",
                "ConditionAncestorTerm":"Neoplasms, Muscle Tissue"
              },{
                "ConditionAncestorId":"D000018204",
                "ConditionAncestorTerm":"Neoplasms, Connective and Soft Tissue"
              },{
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000009372",
                "ConditionAncestorTerm":"Neoplasms, Connective Tissue"
              },{
                "ConditionAncestorId":"D000003240",
                "ConditionAncestorTerm":"Connective Tissue Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafAsFound":"Weighted",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9484",
                "ConditionBrowseLeafName":"Leiomyoma",
                "ConditionBrowseLeafAsFound":"Leiomyoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M24433",
                "ConditionBrowseLeafName":"Myofibroma",
                "ConditionBrowseLeafAsFound":"Leiomyoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M18933",
                "ConditionBrowseLeafName":"Neoplasms, Connective and Soft Tissue",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10900",
                "ConditionBrowseLeafName":"Neoplasms, Connective Tissue",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5047",
                "ConditionBrowseLeafName":"Connective Tissue Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              }
            ]
          }
        }
      }
    }
  }
}