[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644614":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-EV203 PET\u002FCT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies","EXPERIMENTAL",null,[13],"Diagnostic Test: 68Ga-EV203 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIAGNOSTIC_TEST","68Ga-EV203 PET\u002FCT","This arm is distinguished by: (1) a novel CXCR4-targeting cyclic peptide, 68Ga-EV203, with \\>10-fold higher binding affinity than the benchmark 68Ga-Pentixafor, enabling superior tumor-to-background contrast. (2) Four sequential whole-body PET\u002FCT scans at 30, 60, 90, and 120 min post-injection to construct time-activity curves and compute organ-specific absorbed doses (mGy\u002FMBq) and effective dose (mSv\u002FMBq) using OLINDA\u002FEXM-a formal dosimetry endpoint absent in routine diagnostic imaging. (3) Mandatory paired 18F-FDG PET\u002FCT within 3-7 days for direct intrapatient head-to-head diagnostic comparison . (4) Strict enrollment limited to three defined hematological subtypes (MM, NHL, AML) per WHO 2022, with explicit washout periods (≥2 weeks from last anticancer therapy, ≥8 weeks from radiotherapy). (5) A 14-day safety follow-up including laboratory tests (CBC, coagulation, biochemistry) and rigorous contraception requirements for 3 months post-dose.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Heqing Yi","CONTACT","0571-88122020","yihq@zjcc.org.cn",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":35,"coordinates":36},"Point",[37,38],120.16142,30.29365,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","He-Qing Yi","Director of department","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":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"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).",[64],"Hematological Malignancies B","2026-06-23",{"date":67,"type":68},"2026-06-26","ACTUAL",{"date":70,"type":68},"2026-06-01",{"date":72,"type":58},"2029-06-01",{"name":5,"class":6},1]