[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637890":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":34,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"[68Ga]Ga-R54 PET\u002FCT scan","EXPERIMENTAL","Eligible patients with advanced or metastatic breast, pancreatic, colorectal, ovarian, lung cancer or multiple myeloma undergo screening with \\[18F\\]-FDG PET\u002FCT and tumor CXCR4 immunohistochemical analysis on available cyto-histological material. Patients with CXCR4-positive tumors and confirmed eligibility are scheduled to undergo \\[68Ga\\]Ga-R54 PET\u002FCT imaging within 8 days after a positive \\[18F\\]-FDG PET\u002FCT scan. If immunohistochemical assessment is delayed beyond 8 days, a repeat \\[18F\\]-FDG PET\u002FCT may be required to confirm eligibility before proceeding. The \\[68Ga\\]Ga-R54 PET\u002FCT is performed according to protocol and does not interfere with planned therapeutic management. CXCR4-negative patients are considered screening failures and do not undergo investigational imaging.",[13],"Drug: [68Ga]Ga-R54 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[68Ga]Ga-R54 PET\u002FCT","A single intravenous microdose (≤100 μg) of the CXCR4-targeting radiopharmaceutical \\[68Ga\\]Ga-R54 is administered, followed by whole-body PET\u002FCT imaging. Serial blood samples are collected up to 4 hours post-injection to assess pharmacokinetics. Imaging is performed according to institutional standards to evaluate in vivo CXCR4 expression in tumor lesions.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Stefania Scala, M.D.","Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale","STUDY_DIRECTOR",{"name":27,"affiliation":24,"role":28},"Secondo Lastoria, M.D.","PRINCIPAL_INVESTIGATOR",[30],{"name":23,"role":31,"phone":32,"phoneExt":20,"email":33},"CONTACT","08117770596","s.scala@istitutotumori.na.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica","RECRUITING","Naples","Italia","80131","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],14.26811,40.85216,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":20,"phoneExt":20,"email":20},"Secondo Lastoria",{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100637890","early-phase-1-single-microdose-trial--cxcr4-pet-tracer---pharmacokinetics-and-pharmacodynamics-of-68gaga-r54-a-radiopharmaceutical-directed-toward-cxcr4-in-patients-with-advanced-solid-neoplasia-100637890",false,"NCT07577206","Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.","Inclusion Criteria:\n\n* Patients \\> 18 years\n* Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET\u002FCT with \\[18F\\]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry\n* Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET\u002FCT with \\[68Ga\\]Ga-R54).\n* Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase \\\u003C3 x upper limit of reference range and total bilirubin \\\u003C2.0 mg\u002FdL\n* Patients with creatinine \\\u003C 1.5 x upper limit of reference range or 24-hour creatinine clearance \\> 50 mL\u002Fmin\n* Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of \\[68Ga\\]Ga-R54).\n* Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study\n* Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study\n* Declared chronic active hepatitis (hepatitis B \u002F C)\n* Declared active autoimmune diseases\n* Recovery from major trauma including surgery within 4 weeks of study enrollment\n* Presence of neurodegenerative diseases\n* Pregnancy and\u002For breastfeeding\n* Any conditions that in the opinion of the investigator could hinder compliance with the study protocol\n* Patients who have not signed consent to participate in the study","ALL","18 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"EARLY_PHASE1","Phase 1, monocentric, open labeled, no profit \"Microdose\" trial. A single microdose of the new \\[68Ga\\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.",[70,71],"Advanced Solid Tumor","Multiple Myeloma",[73,74,75,76,77,78,79],"\"Microdose\" trial","CXCR4","[68Ga]Ga-R54 PET radiopharmaceutical","pharmacokinetics","pharmacodynamics","advanced solid neoplasia","multiple myeloma","2026-05-05",{"date":82,"type":83},"2026-05-11","ACTUAL",{"date":85,"type":83},"2025-01-24",{"date":87,"type":64},"2027-01",{"name":5,"class":6},1]