{ "FullStudy":{ "Rank":217899, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515384", "OrgStudyIdInfo":{ "OrgStudyId":"18F-AV-133-D01" }, "Organization":{ "OrgFullName":"Avid Radiopharmaceuticals", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Trial of 18F-AV-133 Positron Emission Tomography (PET)", "OfficialTitle":"A Preliminary Evaluation of the Safety and Pancreas Imaging Properties of 18F-AV-133 in Healthy Volunteers and in Patients With Type 1 or Type 2 Diabetes" }, "StatusModule":{ "StatusVerifiedDate":"January 2020", "OverallStatus":"Terminated", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"February 21, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 9, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 13, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Avid Radiopharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.", "DetailedDescription":"The primary objective of this protocol is to address the feasibility for further development of the VMAT2-binding compound 18F-AV-133 as a diagnostic radiopharmaceutical in the field of diabetes. Specifically, this study will evaluate 18F-AV-133 imaging in patients with type 1 diabetes, patients with type 2 diabetes and in healthy controls in order to:\n\nObtain information regarding the safety of 18F-AV-133 in these populations;\nDetermine whether uptake, distribution, or clearance of 18F-AV-133 in the pancreas differs between subjects with predicted reduced beta cell mass (patients with type 1 or type 2 diabetes of long duration) and normal beta cell mass (healthy volunteers);\nEvaluate the PET imaging pharmacokinetics of 18F-AV-133 in abdominal organs of healthy control subjects and patients with type 1 or type 2 diabetes;\nObtain preliminary information regarding the appropriate time window for optimal PET imaging of 18F-AV-133 in the pancreas post-administration for type 1, type 2, and normal healthy individuals;\nObtain preliminary information regarding an appropriate reference tissue for evaluating the PET imaging results of 18F-AV-133 in the pancreas; and\nEvaluate the imaging properties of 18F-AV-133 in the pancreas relative to the brain in a subset of subjects." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 1 Diabetes", "Type 2 Diabetes" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"19", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Type 1 Diabetes", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 18F-AV-133" ] } },{ "ArmGroupLabel":"Type 2 Diabetes", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 18F-AV-133" ] } },{ "ArmGroupLabel":"Healthy Controls", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: 18F-AV-133" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"18F-AV-133", "InterventionDescription":"IV injection, 7.6 mCi (281.2 MBq)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Healthy Controls", "Type 1 Diabetes", "Type 2 Diabetes" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Pancreatic uptake and clearance of 18F-AV-133 tracer as determined by SUVR", "PrimaryOutcomeDescription":"SUVR=standard uptake value ratio", "PrimaryOutcomeTimeFrame":"0-90 minutes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Patients with type 1 diabetes may be enrolled if they meet all of the following criteria:\n\nAre males or females between 18 and 70 years of age, inclusive;\nHave a diagnosis of type 1 diabetes mellitus as defined by ADA criteria; diabetes onset younger than age 21, duration >5 years; Insulin dose requirements ≤ 0.8 units/kg/day;\nHbA1c level ≥ 5% and ≤ 8%;\nHave fasting C-Peptide < 0.1 ng/ml;\nHave a BMI between 18 and 32 kg/m2;\nAble to tolerate PET imaging;\nIn the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and\nGive informed consent.\n\nPatients with type 2 diabetes may be enrolled if they meet all of the following criteria:\n\nAre males or females between 18 and 70 years of age, inclusive;\nMust have been diagnosed with type 2 diabetes for more than five years;\nHbA1c level ≥ 5% and ≤ 8%;\nHave a BMI between 18 and 32 kg/m2;\nGlucose > 200 mg/dl on Mixed Meal Tolerance Test at screening visit;\nAble to tolerate PET imaging;\nIn the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and\nGive informed consent.\n\nHealthy volunteers may be enrolled if they meet all of the following criteria:\n\nAre males or females between 18 and 70 years of age, inclusive;\nHave no history of type 1 or type 2 diabetes in a first degree relative;\nFasting blood glucose ≤ 100 mg/dL;\nHbA1c level ≤ 6%;\nNormal Mixed Meal Tolerance test at screening visit;\nBMI between 18 and 32 kg/m2;\nAble to tolerate PET imaging;\nIn the judgment of the physician, are capable of fasting 4-6 hours prior to screening and Day 1 imaging procedures; and\nGive informed consent.\n\nSubjects will be excluded from enrollment if they meet any of the following criteria:\n\nClinically significant renal dysfunction;\nClinically significant liver dysfunction as determined by history, physical examination, and standard liver function testing at screening (AST, ALT, Total/Direct Bilirubin, Alkaline Phosphatase);\nCoagulopathy;\nUse medications known to affect dopaminergic function, including MAO inhibitors, tetrabenazine, or levodopa;\nRecent (within 3 months) or current treatment with drugs influencing beta cell function or insulin sensitivity (e.g. glucocorticoids, reserpine);\nHave polycystic ovarian syndrome;\nHistory of movement disorder such as Parkinson's Disease, Huntington's Disease;\nClinically significant psychiatric disease or history of psychiatric illness such as depression, bipolar disease, anxiety or schizophrenia;\nCurrent use (within past year) of cocaine, methamphetamine, and/or ecstasy ( MDMA, 34- methylenedioxymethamphetamine;\nHave a recent history of alcohol or substance abuse or dependence;\nClinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (including but not limited to QTc>450 msec);\nClinically significant pulmonary, renal or hepatic impairment, or cancer;\nHave clinically significant infectious disease, including AIDS or HIV infection or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2;\nAre women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using adequate contraception. Women must not be pregnant (negative serum β-HCG at the time of screen) or breastfeeding at screening, and must agree to take appropriate steps not to become pregnant for 30 days following the clinical trial;\nRequire medications with a narrow therapeutic window (e.g., warfarin), are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;\nWeigh more than the manufacturer-recommended limit for the PET/CT camera being used;\nAny prior participation in other research protocols within the past month that involved radiation, with the exception of plain radiography studies (i.e., chest x-rays); and\nHave received a diagnostic or therapeutic radiopharmaceutical within the past week.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Chief Medical Officer", "OverallOfficialAffiliation":"Avid Radiopharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10027", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Type 2 Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5700", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 1", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" } ] } } } } } }