Nctid:
NCT06234319
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005910", "term"=>"Glioma"}], "ancestors"=>[{"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"=>"M9020", "name"=>"Glioma", "asFound"=>"Glioma", "relevance"=>"HIGH"}, {"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"=>"T2519", "name"=>"Glioma", "asFound"=>"Glioma", "relevance"=>"HIGH"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"brain glioma resction specimens"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}, "targetDuration"=>"2 Years", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-03", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Standardised uptake values", "timeFrame"=>"completed within one week after the PET/MRI examination", "description"=>"Standardised uptake values of suspected glioma disease in CXCR4 PET/MRI imaging"}, {"measure"=>"expression of CD34", "timeFrame"=>"completed within one week after surgery", "description"=>"Immunohistochemical evaluation of the expression of CD34 in postoperative tumor tissue"}, {"measure"=>"expression of CXCR4", "timeFrame"=>"completed within one week after surgery", "description"=>"Immunohistochemical evaluation of the expression of CXCR4 in postoperative tumor tissue"}], "secondaryOutcomes"=>[{"measure"=>"SUV and histological grading of glioma", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Correlation between SUV and histological grading of glioma"}, {"measure"=>"CXCR4 expression and histological grading of glioma", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Correlation between CXCR4 expression and histological grading of glioma"}, {"measure"=>"SUV and IDH mutation status", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Correlation between SUV and IDH mutation status"}, {"measure"=>"SUV and 1p/19q deletion status", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Correlation between SUV and 1p/19q deletion status"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Glioma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"33550492", "type"=>"RESULT", "citation"=>"Jacobs SM, Wesseling P, de Keizer B, Tolboom N, Ververs FFT, Krijger GC, Westerman BA, Snijders TJ, Robe PA, van der Kolk AG. CXCR4 expression in glioblastoma tissue and the potential for PET imaging and treatment with [68Ga]Ga-Pentixafor /[177Lu]Lu-Pentixather. Eur J Nucl Med Mol Imaging. 2022 Jan;49(2):481-491. doi: 10.1007/s00259-021-05196-4. Epub 2021 Feb 7."}]}, "descriptionModule"=>{"briefSummary"=>"This project intends to evaluate the role of C-X-C chemokine receptor type 4 (CXCR4) targeted PET/MRI integrated imaging in the grading and molecular typing of brain gliomas, using primary glioma patients as the research subjects and post-operative histopathological analysis as the reference, and to establish an evaluation model for the prognosis of primary glioma patients.", "detailedDescription"=>"1. PET/MRI Scan: Image acquisition was completed 15 days before surgery. CXCR4 contrast agent was injected at 6.5 MBq/kg based on body mass, with no drug extravasation, and imaging was performed after 60 minutes of quiet rest. All subjects were scanned in a supine position on a single bed of the Signa™ 3.0T scanner (GE Healthcare Systems), using a 3.0T gem HNU head coil with a scanning field of view focused on the head. PET acquisition lasted for 20 minutes and was reconstructed using OSEM. Simultaneous MRI acquisition included MR-based attenuation correction (MRAC) - zero echo time pulse sequence (ZTE), as well as structural and functional MRI sequences (T1WI, T2WI, FLAIR, DWI, MRS, DSC, T1-CE). Image fusion was performed on a GE post-processing workstation.\n2. Image Analysis and Observation Indicators: PET/MRI images were independently reviewed and processed by two experienced neuroradiologists. Using IKT-SNAP software, target lesion VOIs were outlined based on FLAIR and T1-CE sequences. VOI delineation on the FLAIR sequence included solid tumor components, necrotic areas, and surrounding abnormal FLAIR signal regions. VOI delineation on the T1-CE sequence included enhanced solid components, non-enhanced solid components, and necrotic areas. MRI parameters (diffusion-weighted imaging parameters: ADC; perfusion imaging parameters: CBF, CBV, MTT, TTP; spectroscopic parameters: NAA, Cho, Cr, Lac, NAA/Cr, Cho/Cr) and PET parameters (SUVmax, SUVmean, SUVpeak, CXCR4 metabolic volume, TBR) were measured throughout the tumor and corresponding regions.\n3. Pathological Analysis: Slices containing no less than 25% tumor tissue were used, with each slice having a thickness of 4um. HE, CD34, and CXCR4 immunohistochemical staining were performed separately. Two senior pathologists reviewed the slides using a double-blind method. IDH mutation status and 1p/19q deletion status were determined by the pathology department."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"The subjects are adults with newly diagnosed primary glioma, regardless of gender.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patients diagnosed with primary glioma based on clinical, imaging, and histopathological criteria;\n2. The patient is at least 18 years old;\n3. Participate in CXCR4 PET/MRI imaging within 15 days before surgery;\n4. Surgical resection of glioma lesion tissue can be used for pathological analysis;\n5. The patient voluntarily participates and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients;\n2. The image quality of the imaging is poor and cannot be used for diagnosis and evaluation;\n3. Molecular typing was not determined by histologic examination;\n4. patients with claustrophobia;\n5. Patients who are allergic to radioactive tracers and MRI contrast agents, and patients with renal insufficiency."}, "identificationModule"=>{"nctId"=>"NCT06234319", "briefTitle"=>"CXCR4 PET/MRI Targeted Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma", "organization"=>{"class"=>"OTHER", "fullName"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"}, "officialTitle"=>"Clinical Study on CXCR4 PET/MRI Targeted Integrated Imaging for Grading Diagnosis, Molecular Typing, and Prognostic Evaluation of Brain Glioma", "orgStudyIdInfo"=>{"id"=>"20230294"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"CXCR4", "type"=>"DIAGNOSTIC_TEST", "description"=>"Patients with clinical suspected primary glioma will receive a CXCR4 PET imaging."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"400000", "city"=>"Chongqing", "state"=>"Chongqing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Chen Xiao", "role"=>"CONTACT", "email"=>"xiaochen229@foxmail.com", "phone"=>"+8615922970174"}, {"name"=>"Du Zhenwei", "role"=>"CONTACT", "email"=>"peter11dzw@126.com", "phone"=>"+8618580503880"}, {"name"=>"Chen Xiao", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Du Zhenwei", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Department of Nuclear Medicine, Daping Hospital of Army Medical University", "geoPoint"=>{"lat"=>29.56278, "lon"=>106.55278}}], "centralContacts"=>[{"name"=>"Du ZHenwei, Ph.D", "role"=>"CONTACT", "email"=>"peter11dzw@126.com", "phone"=>"+8618580503880"}], "overallOfficials"=>[{"name"=>"Chen Xiao, Ph.D", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Daping Hospital, Army Medical University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Xiao Chen", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Director of Nuclear Medicine Department", "investigatorFullName"=>"Xiao Chen", "investigatorAffiliation"=>"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University"}}}}
