A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging
时间窗: 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.
Radioactivity concentration in major organs (including brain, lungs, heart, liver, spleen, kidneys, bladder, bone, and gastrointestinal tract) is quantified as percentage of injected dose (%ID) and mean/maximum standardized uptake values (SUVmean/SUVmax) using three-dimensional volumes of interest (VOIs). Data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) across all participants.
Organ-Specific Radiation Absorbed Doses (mGy/MBq) and Whole-Body Effective Dose (mSv/MBq) Calculated via OLINDA/EXM Software
时间窗: 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.
Time-activity curves (fitted with single- or bi-exponential models) are integrated to obtain cumulated activity for each organ. Absorbed doses (mGy/MBq) and whole-body effective dose (mSv/MBq) are computed using validated dosimetry software (OLINDA/EXM or MIRDcalc) with ICRP reference phantoms. Results will be reported as mean, standard deviation, and range across participants.
Number of Participants with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI-CTCAE Version 5.0
时间窗: 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.
All adverse events and serious adverse events occurring from study drug administration through the final safety visit are recorded and graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Data will be summarized as frequencies and percentages of participants experiencing each type and grade of event.
次要结局
- Tumor-to-Background Ratios (TBR) Derived from PET/CT Images at Four Consecutive Post-Injection Time Points(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.)
研究者
He-Qing Yi
Director of department
Zhejiang Cancer Hospital