{
  "FullStudy":{
    "Rank":217922,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515085",
          "OrgStudyIdInfo":{
            "OrgStudyId":"0220110114"
          },
          "Organization":{
            "OrgFullName":"Rutgers, The State University of New Jersey",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"MRI-Guided Laser Induced Thermal Therapy",
          "OfficialTitle":"MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation",
          "Acronym":"LITT"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2014",
          "OverallStatus":"Terminated",
          "WhyStopped":"PI elected to close study",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"October 18, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 20, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 22, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Rutgers, The State University of New Jersey",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Rutgers Cancer Institute of New Jersey",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.",
          "DetailedDescription":"Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible.\n\nIn this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Malignant Glioma"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Only"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"biopsy proven glioma, no prior treatment",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: laser interstitial thermal therapy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"laser interstitial thermal therapy",
                "InterventionDescription":"residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "biopsy proven glioma, no prior treatment"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "laser ablation",
                    "LITT"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Progression free survival",
                "PrimaryOutcomeTimeFrame":"three years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Overall survival",
                "SecondaryOutcomeTimeFrame":"three years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects that have/will undergo MRgLITT for inoperable brain tumor.\nTumor size < 3cm in transverse diameter for each planned applicator placement.\nTumor size < 4 cm in largest dimension.\nLesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.\nKarnofsky Performance Scale score > 70.\nECOG performance status of 2 or better.\nBiopsy proven histologic diagnosis of malignant glioma.\n\nExclusion Criteria:\n\nPatients with co-existing medical conditions with life expectancy < 1 year.\nPatients having received pre-ablation chemotherapy and/or radiation to lesion.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients with brain tumors receiving MR-guided laser ablation",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Shabbar F Danish, MD",
                "OverallOfficialAffiliation":"Rutgers, The State University of New Jersey",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Robert Wood Johnson University Hospital",
                "LocationCity":"New Brunswick",
                "LocationState":"New Jersey",
                "LocationZip":"08901",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"home page for robert wood johnson brain tumor laser ablation program",
                "SeeAlsoLinkURL":"http://www.rwjuh.edu/laser%2Dablation%2Dfor%2Dbrain%2Dtumor%2Dtreatment/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000005910",
                "ConditionMeshTerm":"Glioma"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000018302",
                "ConditionAncestorTerm":"Neoplasms, Neuroepithelial"
              },{
                "ConditionAncestorId":"D000017599",
                "ConditionAncestorTerm":"Neuroectodermal Tumors"
              },{
                "ConditionAncestorId":"D000009373",
                "ConditionAncestorTerm":"Neoplasms, Germ Cell and Embryonal"
              },{
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000009375",
                "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial"
              },{
                "ConditionAncestorId":"D000009380",
                "ConditionAncestorTerm":"Neoplasms, Nerve Tissue"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M7603",
                "ConditionBrowseLeafName":"Glioma",
                "ConditionBrowseLeafAsFound":"Malignant Glioma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19030",
                "ConditionBrowseLeafName":"Neoplasms, Neuroepithelial",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18428",
                "ConditionBrowseLeafName":"Neuroectodermal Tumors",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18971",
                "ConditionBrowseLeafName":"Neuroectodermal Tumors, Primitive",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10901",
                "ConditionBrowseLeafName":"Neoplasms, Germ Cell and Embryonal",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10903",
                "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10908",
                "ConditionBrowseLeafName":"Neoplasms, Nerve Tissue",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T2531",
                "ConditionBrowseLeafName":"Glioma",
                "ConditionBrowseLeafAsFound":"Glioma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T4119",
                "ConditionBrowseLeafName":"Neuroepithelioma",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}