Clinical Research Directory

Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies

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.). The main questions it aims to answer are: What are the biodistribution (organ uptake, %ID, SUV) and radiation absorbed doses (mGy/MBq) of \^68\^Ga-EV203 in target organs and the whole body? What is the safety profile of \^68\^Ga-EV203, as measured by adverse events and serious adverse events? How does the PET/CT image quality differ between the 30-, 60-, 90-, and 120-minute time points after injection? If there is a comparison group: Researchers will compare the positive percent agreement (PPA) and positive predictive value agreement (PPrA) of \^68\^Ga-EV203 PET/CT against \^18\^F-FDG PET/CT to see if the new tracer offers comparable or superior diagnostic performance in detecting CXCR4-positive lesions. Participants will: Receive a single intravenous injection of 74-296 MBq of \^68\^Ga-EV203. Undergo whole-body PET/CT scans at 30 min, 60 min, 90 min, and 120 min post-injection on the same day. Return within 3-7 days (but at least 2 days later) for a standard \^18\^F-FDG PET/CT scan after fasting for ≥5 h. Attend a safety follow-up visit at day 8-14 for physical examination, vital signs, and laboratory tests (blood count, coagulation, and biochemistry).