[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematological-malignancies-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematological-malignancies-b":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100644614","biodistribution-dosimetry-and-safety-of-68ga-ev203-in-hematological-malignancies-100644614",false,"NCT07670949","Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies","A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive) at screening.\n* Able to lie still on the scanning bed for 0.5 hours.\n* Willing to sign informed consent and able to comply with protocol requirements.\n* Histologically\u002Fcytologically confirmed diagnosis of multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukaemia (AML) according to the 2022 WHO Classification of Haematolymphoid Tumours.\n\nExclusion Criteria:\n\n* Has claustrophobia or any other condition that prevents tolerance of imaging procedures\n* Has undergone major surgery within 3 months prior to screening, or plans to undergo surgery during the study period.\n* Has received any other radiopharmaceutical imaging agent or therapeutic radiopharmaceutical within 30 days prior to screening.\n* Is pregnant or lactating at screening.\n* Is a woman of childbearing potential or a man who does not agree to use effective contraception during the study (from signing informed consent) and for 3 months after study drug administration.\n* Has a known allergy to alcohol or any component of the investigational product, or has other allergies judged by the investigator to increase the participant's risk.\n* Has clinically significant cardiovascular disease within 6 months prior to screening (e.g., myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled severe arrhythmia).\n* Has uncontrolled hypertension, or a history of coagulopathy or coagulation disorders.\n* Has been diagnosed with another malignancy (other than the target haematological disease) within 5 years prior to 68Ga-EV203 administration.\n* Has received any systemic anti-cancer therapy within 2 weeks prior to planned 68Ga-EV203 administration, or radiotherapy within 8 weeks prior to planned administration.\n* Has any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the biodistribution, radiation dosimetry, safety, and time-dependent image quality of \\^68\\^Ga-EV203 injection in patients with hematological malignancies (multiple myeloma, non-Hodgkin lymphoma, or acute myeloid leukaemia), aged 18-75 years, who are able to lie still for 0.5 h and have no contraindications (e.g., pregnancy, recent radiotherapy, etc.).\n\nThe main questions it aims to answer are:\n\nWhat are the biodistribution (organ uptake, %ID, SUV) and radiation absorbed doses (mGy\u002FMBq) of \\^68\\^Ga-EV203 in target organs and the whole body?\n\nWhat is the safety profile of \\^68\\^Ga-EV203, as measured by adverse events and serious adverse events?\n\nHow does the PET\u002FCT image quality differ between the 30-, 60-, 90-, and 120-minute time points after injection?\n\nIf there is a comparison group: Researchers will compare the positive percent agreement (PPA) and positive predictive value agreement (PPrA) of \\^68\\^Ga-EV203 PET\u002FCT against \\^18\\^F-FDG PET\u002FCT to see if the new tracer offers comparable or superior diagnostic performance in detecting CXCR4-positive lesions.\n\nParticipants will:\n\nReceive a single intravenous injection of 74-296 MBq of \\^68\\^Ga-EV203.\n\nUndergo whole-body PET\u002FCT scans at 30 min, 60 min, 90 min, and 120 min post-injection on the same day.\n\nReturn within 3-7 days (but at least 2 days later) for a standard \\^18\\^F-FDG PET\u002FCT scan after fasting for ≥5 h.\n\nAttend a safety follow-up visit at day 8-14 for physical examination, vital signs, and laboratory tests (blood count, coagulation, and biochemistry).",[27],"Hematological Malignancies B","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":32},"2026-06-01",{"date":36,"type":21},"2029-06-01",{"name":38,"class":39},"Zhejiang Cancer Hospital","OTHER"]