Nctid:
NCT06613841
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005909", "term"=>"Glioblastoma"}], "ancestors"=>[{"id"=>"D000001254", "term"=>"Astrocytoma"}, {"id"=>"D000005910", "term"=>"Glioma"}, {"id"=>"D000018302", "term"=>"Neoplasms, Neuroepithelial"}, {"id"=>"D000017599", "term"=>"Neuroectodermal Tumors"}, {"id"=>"D000009373", "term"=>"Neoplasms, Germ Cell and Embryonal"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009380", "term"=>"Neoplasms, Nerve Tissue"}], "browseLeaves"=>[{"id"=>"M9019", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M4561", "name"=>"Astrocytoma", "relevance"=>"LOW"}, {"id"=>"M9020", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"M20446", "name"=>"Neoplasms, Neuroepithelial", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"T2518", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"T2519", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21686", "name"=>"Fluorodeoxyglucose F18", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>15}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-10", "completionDateStruct"=>{"date"=>"2026-10-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-08-28", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"PET uptake values relation to kinetic parameters", "timeFrame"=>"2 years", "description"=>"Correlation of PET uptake values (SUV) and kinetic parameters (volume of distribution) with gene expression of glutamine and glucose metabolism."}, {"measure"=>"Quantification of glutamate and lactate levels", "timeFrame"=>"2 years", "description"=>"The amount of metabolic markers (e.g., glutamate, 5 to 15 mM in normal brain tissue) using 7T MRI. Tumors with high glutamate secretion are associated with increased tumor cell invasiveness."}], "primaryOutcomes"=>[{"measure"=>"Uptake Values (SUV)", "timeFrame"=>"2 years", "description"=>"Quantification of \\[18F\\]Fluciclovine and 18F-FDG uptake values (SUV) in treatment naïve and recurrent GBM."}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Early Phase 1", "Cohort", "Glioblastoma"], "conditions"=>["Glioblastoma", "Recurrent Glioblastoma", "Glioblastoma Multiforme of Brain"]}, "referencesModule"=>{"references"=>[{"pmid"=>"36549916", "type"=>"BACKGROUND", "citation"=>"Nabavizadeh A, Bagley SJ, Doot RK, Ware JB, Young AJ, Ghodasara S, Zhao C, Anderson H, Schubert E, Carpenter EL, Till J, Henderson F Jr, Pantel AR, Chen HI, Lee JYK, Amankulor NM, O'Rourke DM, Desai A, Nasrallah MP, Brem S. Distinguishing Progression from Pseudoprogression in Glioblastoma Using 18F-Fluciclovine PET. J Nucl Med. 2023 Jun;64(6):852-858. doi: 10.2967/jnumed.122.264812. Epub 2022 Dec 22."}]}, "descriptionModule"=>{"briefSummary"=>"* To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \\[18F\\]Fluciclovine and 18F-FDG PET.\n* To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine/glutamate, glucose, and lactate metabolism.\n* To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla", "detailedDescription"=>"Subjects with a new intra-axial brain mass that is consistent with glioblastoma (GBM) on brain MRI or post-treatment histologically or molecularly proven GBM who are suspected to have progression and are candidates for surgical resection according to standard of care may be eligible for this study.\n\nSubjects will undergo approximately 45 minutes of dynamic PET/CT scanning after injection of 2 mCi (±20%) of 18F-Fluciclovine. The subject will have a 60-minute break after this initial scan session, they will be allowed to get off the scanner during this time and encouraged to stay hydrated and void as necessary. Subsequently, the subjects will undergo injection of up to 10 mCi of 18F-FDG followed by a static 20-minute scan approximately 60 minutes post injection. Subjects will have the option to undergo PET/CT imaging with 18F-Fluciclovine and 18F-FDG on separate days as long as the imaging happens within 7 business days. An optional 60-minute brain MRI without contrast will also be performed with the 7.0 Tesla MRI machine. The timing of the optional second PET scans will be within 7 business days of the baseline PET scans.\n\nPositron emission tomography (PET/CT) imaging will be used to evaluate 18F-fluciclovine and 18F-FDG uptake in treatment naïve and recurrent GBM. Brain MR with Chemical Exchange Saturation Transfer (CEST) and MR spectroscopy (MRS) will be used to determine the glutamate and lactate levels. In addition, clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants will be ≥ 18 years of age\n\nMust meet the following criteria:\n\n-Diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist.\n\nOR\n\n* New contrast-enhancing lesion or lesions showing increased enhancement (\\>25%increase) in a patient with a historical diagnosis of glioblastoma (histologic or molecular proof) on standard MRI after completion of treatment\n* Recommended for clinically indicated surgical resection\n* Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.\n* Karnofsky performance status ≥ 60 per medical record review\n* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n* Females who are pregnant or breastfeeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential prior to injection.\n* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study\n* Contraindications to MRI\n* Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study"}, "identificationModule"=>{"nctId"=>"NCT06613841", "acronym"=>"GBM", "briefTitle"=>"Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Abramson Cancer Center at Penn Medicine"}, "officialTitle"=>"Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods At 7Tesla Metabolic Profiling of Glioblastoma", "orgStudyIdInfo"=>{"id"=>"UPCC15324"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Imaging Cohort", "description"=>"Up to 15 subjects will enroll in this imaging study at the University of Pennsylvania. Those with a diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist OR New contrast-enhancing lesion or lesions showing increased enhancement (\\>25% increase) in a patient with a historical diagnosis of glioblastoma.", "interventionNames"=>["Drug: Fluciclovine F18"]}], "interventions"=>[{"name"=>"Fluciclovine F18", "type"=>"DRUG", "description"=>"To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \\[18F\\]Fluciclovine and 18F-FDG PET.", "armGroupLabels"=>["Imaging Cohort"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "contacts"=>[{"name"=>"Leeanne Lezotte", "role"=>"CONTACT", "email"=>"leeanne.lezotte@pennmedicine.upenn.edu", "phone"=>"8563643137"}, {"name"=>"Jeremy T Westerman, B.S.", "role"=>"CONTACT", "email"=>"jeremy.westerman@pennmedicine.upenn.edu", "phone"=>"2159199110"}, {"name"=>"Ali Nabavizadeh, MD", "role"=>"CONTACT"}], "facility"=>"University of Pennsylvania", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}], "centralContacts"=>[{"name"=>"Leeanne Lezotte", "role"=>"CONTACT", "email"=>"leeanne.lezotte@pennmedicine.upenn.edu", "phone"=>"8563643137"}, {"name"=>"Jeremy T Westerman, B.S.", "role"=>"CONTACT", "email"=>"jeremy.westerman@pennmedicine.upenn.edu", "phone"=>"2159199110"}], "overallOfficials"=>[{"name"=>"Ali Nabavizadeh, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Pensylvania"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Abramson Cancer Center at Penn Medicine", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Ali Nabavizadeh", "investigatorAffiliation"=>"Abramson Cancer Center at Penn Medicine"}}}}
