Hematological Malignancies BNCT07670949
Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies
A study testing 68Ga-EV203 PET/CT in people with Hematological Malignancies B, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancies B
- What is being tested?
- 68Ga-EV203 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Heqing Yi, 0571-88122020, yihq@zjcc.org.cn
About this study
Official title: A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With 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:
Read more
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
- Hematological Malignancies B
- Being tested
- 68Ga-EV203 PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-EV203 PET/CTDiagnostic test
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) Mandatory paired 18F-FDG PET/CT within 3-7 days for direct intrapatient head-to-head diagnostic comparison . (4) Strict enrollment limited to three defined hematological subtypes (MM, NHL, AML) per WHO 2022, with explicit washout periods (≥2 weeks from last anticancer therapy, ≥8 weeks from radiotherapy). (5) A 14-day safety follow-up including laboratory tests (CBC, coagulation, biochemistry) and rigorous contraception requirements for 3 months post-dose.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-EV203 PET/CT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies | Experimental | Not described Receives: Diagnostic Test: 68Ga-EV203 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging
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.
Measured: 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-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.
Measured: 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
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.
Measured: 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 outcomes (1)
Tumor-to-Background Ratios (TBR) Derived from PET/CT Images at Four Consecutive Post-Injection Time Points
Tumor-to-background ratios (lesion SUVmax divided by liver SUVmean and by blood-pool SUVmean) are calculated at 30, 60, 90, and 120 minutes after injection to evaluate time-dependent image quality. Differences across time points will be summarized using paired descriptive statistics (means and standard deviations).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological Malignancies BStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He-Qing Yi, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670949
- Sponsor's protocol ID
- IRB-2026-483
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07670949
- Acronym / sponsor ID
- IRB-2026-483
- Conditions
- Hematological Malignancies B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-EV203 PET/CT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies | Experimental | Diagnostic Test: 68Ga-EV203 PET/CT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-EV203 PET/CTThis 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) Mandatory paired 18F-FDG PET/CT within 3-7 days for direct intrapatient head-to-head diagnostic comparison . (4) Strict enrollment limited to three defined hematological subtypes (MM, NHL, AML) per WHO 2022, with explicit washout periods (≥2 weeks from last anticancer therapy, ≥8 weeks from radiotherapy). (5) A 14-day safety follow-up including laboratory tests (CBC, coagulation, biochemistry) and rigorous contraception requirements for 3 months post-dose. | Diagnostic test | 68Ga-EV203 PET/CT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies |
Primary outcome
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.
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
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.
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
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-EV203 PET/CT in people with Hematological Malignancies B, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heqing Yi (0571-88122020, yihq@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.