{ "FullStudy":{ "Rank":217782, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516905", "OrgStudyIdInfo":{ "OrgStudyId":"RO11310" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"1R01CA158800-01", "SecondaryIdType":"U.S. NIH Grant/Contract", "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=1R01CA158800-01&Fy=all" },{ "SecondaryId":"NCI-2012-02042", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NCI Trial ID" },{ "SecondaryId":"2011-0452", "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":"PET/CT Imaging of Malignant Brain Tumors With 124I-NM404", "OfficialTitle":"PET/CT Imaging of Malignant Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue 124I-NM404" }, "StatusModule":{ "StatusVerifiedDate":"February 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 17, 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 17, 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 13, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 15, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University of Wisconsin, Madison", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"National Cancer Institute (NCI)", "CollaboratorClass":"NIH" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in humans with brain metastases and GBMs. This goal will be accomplished by determining the optimal PET/CT protocol and comparing PET tumor uptake to MRI and calculating tumor dosimetry. A future aim of this study will be to compare non-invasive PET/CT and MRI findings with pathological specimens, which is the gold standard but is invasive and impractical in many cases, to determine the sensitivity and specificity of both techniques for accurately detecting tumor infiltration. The data obtained from this study will be used to develop larger diagnostic and therapeutic trials in brain tumors. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Glioblastoma", "Brain Metastases" ] } }, "DesignModule":{ "StudyType":"Observational", "PatientRegistry":"No", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"19", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"I124-NM404 brain metastases or GBM imaging", "ArmGroupDescription":"determining appropriate imaging timepoints. Image at 6 hour, 24 hour and 48 hour post injection of I-124NM404", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: NM404" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"NM404", "InterventionDescription":"injection of either 2.0mCi or 5.0mCi I-124 NM404", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "I124-NM404 brain metastases or GBM imaging" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "PET imaging with I-124 NM404" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"tumor to background ratios", "PrimaryOutcomeDescription":"patients will be imaged at 3 different times out to 48 hrs post injection. Images will be evaluated based on tumor/background, dimensions/volumes and a qualitative score", "PrimaryOutcomeTimeFrame":"48hrs" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParticipants will have a contrast enhanced brain MRI which documents evidence of GBM or metastatic brain tumor\nTumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion\nFemale patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of I-124 NM404. Participants must not attempt to become pregnant during this time\nPlatelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy\nKarnofsky score ≥ 60\nFor brain metastases patients: targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404\nFor GBM tumors confirmed by surgical biopsy or suspected by MRI: no previous surgical resection (except for biopsy) or systemic or radiation therapy targeted to the GBM tumor -\n\nExclusion Criteria:\n\nLife expectancy of < 3 months\nAllergy to potassium iodide (SSKI or Thyroshield)\nPlanned surgical resection or biopsy after injection of 124I-NM404 and prior to completion of the 3rd PET/CT scan\nUnwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days -", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"Subjects will be recruited when seen by oncologists in the UWCCC clinic.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Lance Hall, MD", "OverallOfficialAffiliation":"University of Wisconsin, Madison", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Scott Perlman, MD, MS", "OverallOfficialAffiliation":"University of Wisconsin, Madison", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Wisconsin Hospital and Clinics", "LocationCity":"Madison", "LocationState":"Wisconsin", "LocationZip":"53792", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"University of Wisconsin Carbone Cancer Center", "SeeAlsoLinkURL":"https://cancer.wisc.edu/" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000005909", "ConditionMeshTerm":"Glioblastoma" },{ "ConditionMeshId":"D000001932", "ConditionMeshTerm":"Brain Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000001254", "ConditionAncestorTerm":"Astrocytoma" },{ "ConditionAncestorId":"D000005910", "ConditionAncestorTerm":"Glioma" },{ "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":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009380", "ConditionAncestorTerm":"Neoplasms, Nerve Tissue" },{ "ConditionAncestorId":"D000016543", "ConditionAncestorTerm":"Central Nervous System Neoplasms" },{ "ConditionAncestorId":"D000009423", "ConditionAncestorTerm":"Nervous System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3791", "ConditionBrowseLeafName":"Brain Neoplasms", "ConditionBrowseLeafAsFound":"Malignant Brain Tumors", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7602", "ConditionBrowseLeafName":"Glioblastoma", "ConditionBrowseLeafAsFound":"Glioblastoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3142", "ConditionBrowseLeafName":"Astrocytoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7603", "ConditionBrowseLeafName":"Glioma", "ConditionBrowseLeafRelevance":"low" },{ "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":"M17520", "ConditionBrowseLeafName":"Central Nervous System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10950", "ConditionBrowseLeafName":"Nervous System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2530", "ConditionBrowseLeafName":"Glioblastoma", "ConditionBrowseLeafAsFound":"Glioblastoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T2531", "ConditionBrowseLeafName":"Glioma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4119", "ConditionBrowseLeafName":"Neuroepithelioma", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }