[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594542":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":67,"collaborators":70,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":17,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":17,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":17,"overallStatus":50,"whyStopped":17,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of California, Davis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"The ability of [68Ga]Ga DOTA-5G PET\u002FCT imaging to detect lesions","To assess the ability of \\[68Ga\\]Ga DOTA-5G PET\u002FCT imaging to detect lesions. Following injection of \\[68Ga\\]Ga DOTA-5G patients will be imaged at 1 and 2 hours. Regions of interest will be drawn around lesions and standard uptake values (SUV) calculated. Detection of metastasis by \\[68Ga\\]Ga DOTA-5G PET\u002FCT imaging, positive vs. negative based on if SUVmax \\>2-fold above normal brain, bone, lung, or liver of \\[68Ga\\]Ga DOTA-5G in at least one lesion assessed by \\[68Ga\\]Ga DOTA-5G PET\u002FCT and identified on \\[18F\\]-FDG PET\u002FCT diagnostic imaging.","2 hours from time of injection",{"measure":14,"description":15,"timeFrame":16},"Safety and tolerability of [68Ga]Ga DOTA-5G based on the incidence of adverse events using CTCAE v 5.0","To evaluate the safety and tolerability of \\[68Ga\\]Ga DOTA-5G patients will be followed for up to 7 days for AEs using CTCAE v 5.0.","Up to 7 days from time of injection",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","This is a phase I investigator-initiated study that will investigate \\[68Ga\\]Ga DOTA-5G in patients with metastatic\u002Fadvanced invasive LBC. 30 patients diagnosed with LBC will be enrolled over a 24-month period.\n\nWe hypothesize that a) \\[68Ga\\]Ga DOTA-5G will detect lesions in patients with invasive LBC, b) \\[68Ga\\]Ga DOTA-5G will be safe and well tolerated, and that c) \\[68Ga\\]Ga DOTA-5G PET\u002FCT is more sensitive than 18F-FDG PET\u002FCT at detecting lesions.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"[68Ga]Ga-DOTA-5G PET\u002FCT imaging","EXPERIMENTAL","Following an injection of up to 5 mCi of \\[68Ga\\]Ga DOTA-5G patients will be undergo PET\u002FCT scans.",[31],"Drug: [68Ga]Ga DOTA-5G",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"DRUG","[68Ga]Ga DOTA-5G","Patients will be injected with up to 5 mCi of \\[68Ga\\]Ga DOTA-5G and imaged at 1 and 2 hours post injection.",[27],[39],{"name":40,"affiliation":5,"role":41},"Julie Sutcliffe, PhD","PRINCIPAL_INVESTIGATOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":17,"email":46},"CONTACT","916-734-5536","jlsutcliffe@health.ucdavis.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of California Davis","RECRUITING","Sacramento","California","95817","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-121.4944,38.58157,{"lat":60,"lon":59},[63,65],{"name":64,"role":44,"phone":45,"phoneExt":17,"email":46},"Julie L Sutcliffe",{"name":66,"role":41,"phone":17,"phoneExt":17,"email":17},"Julie Sutcliffe",{"type":41,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Julie L. Sutcliffe, Ph.D","Professor",[71,74,76],{"name":72,"class":73},"Dr. Helen K Chew, University of California Davis","UNKNOWN",{"name":75,"class":73},"Dr. Cameron Foster, University of California Davis",{"name":77,"class":73},"Society of Nuclear Medicine and Molecular Imaging","100594542","phase-1-68gaga-dota-5g-as-a-diagnostic-imaging-agent-for-metastaticadvanced-invasive-lobular-breast-cancer-lbc-100594542",false,"NCT07020806","[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic\u002FAdvanced Invasive Lobular Breast Cancer (LBC)","Inclusion Criteria:\n\n* (Ability to understand and willingness to sign a written informed consent document.\n* Men and women age ≥ 18 yrs\n* Confirmed presence of metastatic\u002Fadvanced invasive lobular breast cancer and measurable disease per RECIST (version 1.1) or PERCIST\n* Available archival tumor tissue\n* Eastern Cooperative Oncology Group Performance Status ≤ 2\n* Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3,Platelet count ≥ 100,000\u002Fmm3, Hemoglobin ≥ 8 g\u002FdL.\n* Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN), Total bilirubin ≤ 2 times ULN, eGFR \\>60 mL\u002Fmin\u002F1.73m\\*2\n* Anticipated life expectancy ≥ 3 months\n* Able to remain motionless for up to 30-60 minutes per scan.\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Prisoners\n* Concurrent malignancy of a different histology that could confound imaging interpretation.\n* Patients who cannot undergo PET\u002FCT scanning because of weight limits(\\>350lbs)","ALL","18 Years","89 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","This is a prospective study using \\[68Ga\\]Ga DOTA-5G PET\u002FCT imaging in patients diagnosed with metastatic\u002Fadvanced invasive lobular breast cancer (LBC).",[95],"Metastatic Lobular Breast Carcinoma","2026-09-09",{"date":98,"type":99},"2026-09-14","ACTUAL",{"date":101,"type":99},"2025-11-18",{"date":103,"type":89},"2027-06",{"name":5,"class":6},1]