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).
Age 18 to 75 years (inclusive) at screening.
Able to lie still on the scanning bed for 0.5 hours.
Willing to sign informed consent and able to comply with protocol requirements.
Histologically/cytologically confirmed diagnosis of multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukaemia (AML) according to the 2022 WHO Classification of Haematolymphoid Tumours.
Has claustrophobia or any other condition that prevents tolerance of imaging procedures
Has undergone major surgery within 3 months prior to screening, or plans to undergo surgery during the study period.
Has received any other radiopharmaceutical imaging agent or therapeutic radiopharmaceutical within 30 days prior to screening.
Is pregnant or lactating at screening.