Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies B | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-EV203 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-EV203 PET/CT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies
- interventionNames
- Diagnostic Test: 68Ga-EV203 PET/CT
Primary outcomes (3)
- measure
- Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging
- timeFrame
- 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.
- description
- 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.
- measure
- Organ-Specific Radiation Absorbed Doses (mGy/MBq) and Whole-Body Effective Dose (mSv/MBq) Calculated via OLINDA/EXM Software
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available