Nctid:
NCT06612567
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21258", "name"=>"Radiopharmaceuticals", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>120}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-07", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation.", "timeFrame"=>"Baseline", "description"=>"Detection normal variants and pitfalls of 18F-FDG PET/CT Imaging in Pediatric oncology that interfere in PET/CT study results and interpretation by follow up with PET/CT or other imagining or clinically"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pitfalls of PET Scan on Pediattic"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"https://doi.org/10.3389/fnume.2022.825891"}, {"pmid"=>"17515398", "type"=>"BACKGROUND", "citation"=>"Smith CS, Schoder H, Yeung HW. Thymic extension in the superior mediastinum in patients with thymic hyperplasia: potential cause of false-positive findings on 18F-FDG PET/CT. AJR Am J Roentgenol. 2007 Jun;188(6):1716-21. doi: 10.2214/AJR.06.0552."}, {"pmid"=>"33586403", "type"=>"BACKGROUND", "citation"=>"Bicakci N, Elli M. 18Fluorine-fluorodeoxyglucose PET/CT Imaging in Childhood Malignancies. Mol Imaging Radionucl Ther. 2021 Feb 9;30(1):18-27. doi: 10.4274/mirt.galenos.2020.64436."}, {"pmid"=>"33334912", "type"=>"BACKGROUND", "citation"=>"Vali R, Alessio A, Balza R, Borgwardt L, Bar-Sever Z, Czachowski M, Jehanno N, Kurch L, Pandit-Taskar N, Parisi M, Piccardo A, Seghers V, Shulkin BL, Zucchetta P, Lim R. SNMMI Procedure Standard/EANM Practice Guideline on Pediatric 18F-FDG PET/CT for Oncology 1.0. J Nucl Med. 2021 Jan;62(1):99-110. doi: 10.2967/jnumed.120.254110."}]}, "descriptionModule"=>{"briefSummary"=>"Detection Normal variants and pitfalls of 18_F _FDG PET/CT imaging in pediatic oncology.", "detailedDescription"=>"Although pediatric cancer is relatively rare compared with adult cancer, it is the second most common cause of death, after injury in children and adolescents. lymphoma, Leukemia, and brain cancer, account for more than half of pediatric cancers, followed by neuroblastoma, soft-tissue sarcomas, Wilms tumors, and bone tumors .\n\n18Fluorine-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) plays an important role, staging, restaging, response to treatment in childhood malignancies. PET-only examinations have been replaced by hybrid systems in the recent decades, where PET and CT are used together in oncology. In this imaging system, PET and CT are used together for functional data and morphological information, respectively. (2) Although 18F-FDG PET/CT is now well established as an accurate method for the staging and restaging of various cancers, it is also well recognized that many false-positive results can occur .\n\nThe normal distribution of FDG uptake in children differs from adults. Also, even though FDG is used widely in oncology, it is not tumor specific. Uptake of FDG may be seen in numerous benign conditions, including inflammation, infection, and trauma. Proper interpretation of pediatric FDG PET/CT studies requires knowledge of the normal distribution of FDG uptake in children, and an insight into the physiologic variants, benign lesions, and PET/CT related artifacts.\n\nBy understanding the potential causes of misinterpretation, we can increase the accuracy of interpretation, decrease the number of unnecessary follow-up studies and improve treatment outcome."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Pediatric patients that will underwent PET/CT scan", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* All Pediatric Cancer patients referred to nuclear medicine unit to do 18F-FDG PET/CT study.\n\nAll patients \\> or = 18 years.\n\nExclusion Criteria:\n\n* Severely ill patients. Patients with glucose level \\< 200 mg/dl."}, "identificationModule"=>{"nctId"=>"NCT06612567", "briefTitle"=>"Normal Variants and Pitfalls of 18F_FDG PET/CT in Pediatric Oncology", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"Normal Variants and Pitfalls of 18F_FDG PET/CT Imaging in Pediatric Oncology", "orgStudyIdInfo"=>{"id"=>"Pitfalls PET/CT In pediatric"}}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"PET/CT", "type"=>"DIAGNOSTIC_TEST", "description"=>"is an imaging test that can help reveal the metabolic or biochemical function of your tissues and organs. The PET scan uses a radioactive drug called a tracer to show both typical and atypical metabolic activity. A PET scan can often detect the atypical metabolism of the tracer in diseases before the disease shows up on other imaging tests, such as computerized tomography (CT) and magnetic resonance imaging (MRI)."}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Amira Atef Mohamed, Resident doctor", "role"=>"CONTACT", "email"=>"ameraatef781@gmail.com", "phone"=>"+20 1017064445"}, {"name"=>"Waleed Ahmed Diaab, Ass.prof", "role"=>"CONTACT", "email"=>"Waleed.diab@aun.edu.eg", "phone"=>"+201004242213"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr", "investigatorFullName"=>"Amira Atef Mohamed", "investigatorAffiliation"=>"Assiut University"}}}}
