Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-EV203 PET/CT.
- Who it may be relevant to
- Registry conditions: Hematological Malignancies B. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies
Overview
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).
Interventions
- Diagnostic test 68Ga-EV203 PET/CT
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/CT scans at 30, 60, 90, and 120 min post-injection to construct time-activity curves and compute organ-specific absorbed doses (mGy/MBq) and effective dose (mSv/MBq) using OLINDA/EXM-a formal dosimetry endpoint absent in routine diagnostic imaging. (3) Man
Primary outcome measures
- Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging [Time frame: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.]
- Organ-Specific Radiation Absorbed Doses (mGy/MBq) and Whole-Body Effective Dose (mSv/MBq) Calculated via OLINDA/EXM Software [Time frame: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.]
- Number of Participants with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI-CTCAE Version 5.0 [Time frame: Adverse event monitoring begins from the time of injection on Day 1 and continues through the safety follow-up visit, which occurs between Day 8 and Day 14 post-injection.]
Secondary outcome measures (1)
- Tumor-to-Background Ratios (TBR) Derived from PET/CT Images at Four Consecutive Post-Injection Time Points [Time frame: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
- 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.
- Has clinically significant cardiovascular disease within 6 months prior to screening (e.g., myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled severe arrhythmia).
- Has uncontrolled hypertension, or a history of coagulopathy or coagulation disorders.
- Has been diagnosed with another malignancy (other than the target haematological disease) within 5 years prior to 68Ga-EV203 administration.
- 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.
- Has any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07670949 · IRB-2026-483