Nctid:
NCT06232122
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010051", "term"=>"Ovarian Neoplasms"}, {"id"=>"D000077216", "term"=>"Carcinoma, Ovarian Epithelial"}, {"id"=>"D000012008", "term"=>"Recurrence"}], "ancestors"=>[{"id"=>"D000004701", "term"=>"Endocrine Gland Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010049", "term"=>"Ovarian Diseases"}, {"id"=>"D000000291", "term"=>"Adnexal Diseases"}, {"id"=>"D000005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000006058", "term"=>"Gonadal Disorders"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "asFound"=>"Recurrent Tumors", "relevance"=>"HIGH"}, {"id"=>"M12974", "name"=>"Ovarian Neoplasms", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M7863", "name"=>"Endocrine Gland Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12972", "name"=>"Ovarian Diseases", "relevance"=>"LOW"}, {"id"=>"M3643", "name"=>"Adnexal Diseases", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9163", "name"=>"Gonadal Disorders", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000019788", "term"=>"Fluorodeoxyglucose F18"}, {"id"=>"C000706531", "term"=>"FAPI-46"}], "ancestors"=>[{"id"=>"D000019275", "term"=>"Radiopharmaceuticals"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M21686", "name"=>"Fluorodeoxyglucose F18", "asFound"=>"ICH", "relevance"=>"HIGH"}, {"id"=>"M93068", "name"=>"FAPI-46", "asFound"=>"Tonic", "relevance"=>"HIGH"}, {"id"=>"M21258", "name"=>"Radiopharmaceuticals", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2028-07-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-20", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-07-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset", "timeFrame"=>"2 months for individual participants to complete all visits", "description"=>"Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4).\n\nCancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study."}], "secondaryOutcomes"=>[{"measure"=>"Progression-free survival (PFS)", "timeFrame"=>"5 years", "description"=>"Progression-free survival (PFS) is defined as the duration (months) from the initiation of further therapy to disease progression assessed by Gynecological Cancer Intergroup (GCIG) guideline which incorporates both RECIST 1.1 and CA125 or to death."}, {"measure"=>"Overall Survival (OS)", "timeFrame"=>"5 years", "description"=>"Overall survival (OS) is defined as the duration (months) from the 68Ga-FAPI-46 PET/CT study to death."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["68Ga-FAPI-46", "18F-FDG", "CA-125"], "conditions"=>["Ovarian Cancer"]}, "descriptionModule"=>{"briefSummary"=>"A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy", "detailedDescription"=>"Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pathologically proven ovarian cancer with complete response after therapy\n* Age between 30 and 80\n* Elevation of serum CA125 value above the normal range (\\>35 U/mL) or doubling of serum CA125 value within the normal range\n* ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed\n* Willing to enter this prospective study with signed informed consent form\n\nExclusion Criteria:\n\n* Patients with history of other malignancy\n* Patients who are pregnant or lactating\n* Patients with fasting fingerstick glucose level higher than 200 mg/dl\n* Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies\n* Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators"}, "identificationModule"=>{"nctId"=>"NCT06232122", "briefTitle"=>"Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Chang Gung Memorial Hospital"}, "officialTitle"=>"Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer With CA125 Elevation From Complete Response After Therapy", "orgStudyIdInfo"=>{"id"=>"202102208A0"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"68Ga-FAPI ,PET/CT", "description"=>"Inject 68Ga-FAPI and then perform PET/CT scan.", "interventionNames"=>["Diagnostic Test: 68Ga-FAPI-46", "Diagnostic Test: 18F-FDG"]}], "interventions"=>[{"name"=>"68Ga-FAPI-46", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["68Ga-fibroblast activating protein inhibitors"], "description"=>"Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46", "armGroupLabels"=>["68Ga-FAPI ,PET/CT"]}, {"name"=>"18F-FDG", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["18F-fluorodeoxyglucose"], "description"=>"Intravenous injection of one dosage of 5-10mCi 18F-FDG", "armGroupLabels"=>["68Ga-FAPI ,PET/CT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Taoyuan City", "status"=>"RECRUITING", "country"=>"Taiwan", "contacts"=>[{"name"=>"Feng-Yuan Liu", "role"=>"CONTACT", "email"=>"billiu@cgmh.org.tw", "phone"=>"(+886)975365782"}], "facility"=>"Chang-Gung Memorial Hospital, Linkou Branch", "geoPoint"=>{"lat"=>24.95233, "lon"=>121.20193}}], "centralContacts"=>[{"name"=>"Feng-Yuan Liu", "role"=>"CONTACT", "email"=>"billliu@cgmh.org.tw", "phone"=>"0975365782"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Chang Gung Memorial Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Feng-Yuan Liu, MD", "investigatorAffiliation"=>"Chang Gung Memorial Hospital"}}}}
