[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637890":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":11,"armGroups":29,"interventions":36,"overallOfficials":42,"centralContacts":50,"locations":55,"responsibleParty":73,"collaborators":11,"id":75,"slug":11,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the \"maximum standardized uptake value\" (SUVmax).",null,"Single time point at PET\u002FCT imaging (Day 1)",{"measure":14,"description":11,"timeFrame":15},"Pharmacokinetics of the PET radiopharmaceutical [68Ga]Ga-R54 through measurement of radioactivity in blood at the gamma counter (%ID\u002Fg).","Peri-procedural (at time of PET\u002FCT imaging, Day 1)",[17,20],{"measure":18,"description":11,"timeFrame":19},"Evaluation of the dosimetric parameters for the tumor and for healthy organs by determining the absorbed dose per unit of activity administered (mGy\u002FMBq).","From time of [68Ga]Ga-R54 administration up to 4 hours post-injection",{"measure":21,"description":11,"timeFrame":12},"SUVmax correlation of the radiopharmaceutical [68Ga]Ga-R54 and CXCR4 expression assessed by immunohistochemistry in the tumor and microenvironment.",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":27,"maskingDescription":11,"whoMasked":11},"NONE","The present study aims to evaluate the pharmacokinetic\u002Fpharmacodynamic profile and the engagement capacity of a new PET probe that binds the CXCR4 receptor. A Microdose-Trial (Guideline ICH M3(R2) CPMP\u002FICH\u002F286\u002F95 type 1 approach and EMEA\u002FCHMP\u002FSWP\u002F28367\u002F07 Rev. 1) is proposed in order to evaluate the pharmacokinetics and pharmacodynamics of a single microdose of the radiopharmaceutical \\[68Ga\\]Ga-R54 in patients suffering from solid tumors in the advanced stage of the disease or multiple myeloma. At least 5 and no more than 10 consenting patients with advanced solid tumors (breast, lung, colon, ovary, and pancreas) or multiple myeloma will be recruited with at least 1 patient per pathology whose neoplasm expresses CXCR4. Study patients will receive i.v. a single dose of \\[68Ga\\]Ga-R54 ≤100 μg. The localization of the target will be carried out with PET\u002FCT method. Pharmacokinetics will be analyzed by blood samples taken at 2, 5, 10, 30 minutes, 1, 2 and 4 hours post infusion. Patients will be enrolled at least 7 days apart to monitor the onset of adverse events.",[30],{"label":31,"type":32,"description":33,"interventionNames":34},"[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.",[35],"Drug: [68Ga]Ga-R54 PET\u002FCT",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"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.",[31],[43,47],{"name":44,"affiliation":45,"role":46},"Stefania Scala, M.D.","Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale","STUDY_DIRECTOR",{"name":48,"affiliation":45,"role":49},"Secondo Lastoria, M.D.","PRINCIPAL_INVESTIGATOR",[51],{"name":44,"role":52,"phone":53,"phoneExt":11,"email":54},"CONTACT","08117770596","s.scala@istitutotumori.na.it",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica","RECRUITING","Naples","Italia","80131","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],14.26811,40.85216,{"lat":68,"lon":67},[71],{"name":72,"role":52,"phone":11,"phoneExt":11,"email":11},"Secondo Lastoria",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":83,"type":84},10,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91],"Advanced Solid Tumor","Multiple Myeloma",[93,94,95,96,97,98,99],"\"Microdose\" trial","CXCR4","[68Ga]Ga-R54 PET radiopharmaceutical","pharmacokinetics","pharmacodynamics","advanced solid neoplasia","multiple myeloma","2026-05-05",{"date":102,"type":103},"2026-05-11","ACTUAL",{"date":105,"type":103},"2025-01-24",{"date":107,"type":84},"2027-01",{"name":5,"class":6},1]