Nctid:
NCT06612580
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12-31", "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"=>"2025-08-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Diagnostic value", "timeFrame"=>"through study completion, an average of 3 months", "description"=>"Sensitivity and Specificity of 68Ga-AAZTA-NI-093 for prostate cancer in comparison with 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT."}], "primaryOutcomes"=>[{"measure"=>"Adverse events", "timeFrame"=>"Within 7 days following PET/CT", "description"=>"The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0."}], "secondaryOutcomes"=>[{"measure"=>"Dosimetry data", "timeFrame"=>"through study completion, an average of 3 months", "description"=>"Calculate the absorbed dose of 68Ga-AAZTA-NI-093 in normal organs."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["PSMA", "Prostate cancer"], "conditions"=>["Prostate Cancer (Adenocarcinoma)"]}, "descriptionModule"=>{"briefSummary"=>"68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in patients with prostate cancer.", "detailedDescription"=>"Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-NI-093 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* confirmed treated or untreated prostate cancer patients;\n* signed written consent.\n\nExclusion Criteria:\n\n* known allergy against PSMA;\n* any medical condition that in the opinion of the investigator may significantly interfere with study compliance."}, "identificationModule"=>{"nctId"=>"NCT06612580", "briefTitle"=>"68Ga-AAZTA-NI-093 PET/CT: First-in-human Study", "organization"=>{"class"=>"OTHER", "fullName"=>"First Affiliated Hospital of Fujian Medical University"}, "officialTitle"=>"68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer", "orgStudyIdInfo"=>{"id"=>"FAHFJ-68Ga-AAZTA-NI-093"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"68Ga-AAZTA-NI-093 PET/ CT", "description"=>"68Ga-AAZTA-NI-093 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-NI-093. Tracer doses of 68Ga-AAZTA-NI-093 will be used to image lesions of prostate cancer by PET/CT", "interventionNames"=>["Drug: 68Ga-AAZTA-NI-093"]}], "interventions"=>[{"name"=>"68Ga-AAZTA-NI-093", "type"=>"DRUG", "description"=>"Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-NI-093. Tracer doses of 68Ga-AAZTA-NI-093 will be used to image lesions of prostate cancer by PET/CT.", "armGroupLabels"=>["68Ga-AAZTA-NI-093 PET/ CT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"350005", "city"=>"Fuzhou", "state"=>"Fujian", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Weibing Miao, MD", "role"=>"CONTACT", "email"=>"miaoweibing@126.com", "phone"=>"+86-0591-87981618"}, {"name"=>"Guochang Wang, MD", "role"=>"CONTACT", "email"=>"guochang1007@163.com", "phone"=>"+86-0591-87981619"}], "facility"=>"The First Affiliated Hospital of Fujian Medical University", "geoPoint"=>{"lat"=>26.06139, "lon"=>119.30611}}], "centralContacts"=>[{"name"=>"Weibing Miao, MD", "role"=>"CONTACT", "email"=>"miaoweibing@126.com", "phone"=>"86-0591-87981618"}, {"name"=>"Guochang Wang, MD", "role"=>"CONTACT", "email"=>"guochang1007@163.com", "phone"=>"86-0591-87981619"}], "overallOfficials"=>[{"name"=>"Weibing Miao, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"First Affiliated Hospital of Fujian Medical University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"First Affiliated Hospital of Fujian Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
