Multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukemia (AML)
Conditions
Interventions
Experimental group:68ga-ev203 injection
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years (inclusive) at the time of screening; 2. Able to lie on the scanning bed for 0.5 hours; 3. Voluntarily sign the informed consent form and be able to complete the study according to the protocol requirements; 4. Histologically/cytologically confirmed multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukemia (AML), according to the 2022 5th edition WHO classification of hematopoietic and lymphoid tumors.
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate imaging procedures due to claustrophobia or other reasons; 2. Received any surgical procedure within 3 months prior to screening or planned to undergo surgery during the trial; Subjects who received other radiopharmaceutical imaging or therapy within 30 days prior to screening; 3. Pregnant or breastfeeding at screening, or women of childbearing potential (premenopausal or within 2 years postmenopause and not surgically sterilized) who do not agree to use effective contraception (such as complete abstinence, condoms, intrauterine devices, etc.) during the trial (starting from signing the informed consent) and for 3 months after dosing; Men who plan to conceive or donate sperm during the trial (starting from signing the informed consent) and for 3 months after dosing, or who are unwilling to use effective contraception (such as complete abstinence, condoms, surgical sterilization, etc.); 4. Subjects allergic to alcohol or with other allergy histories that, in the investigator’s judgment, may increase trial risk; 5. Clinically significant cardiovascular disease within 6 months prior to screening (including but not limited to myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled severe arrhythmias); uncontrolled hypertension; history of coagulation disorders or presence of coagulation abnormalities; history of other malignancies (excluding the disease under study) within 5 years prior to dosing; 6. Any drugs or treatments that may interfere with trial data or may cause serious adverse reactions and have not been fully eliminated before enrollment, as judged by the investigator (less than 2 weeks between the last anti-tumor therapy and planned 68Ga-EV203 administration, or less than 8 weeks since the last radiotherapy); Other conditions deemed by the investigator as unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole-body scan images obtained by positron emission tomography (PET);Accumulation in target organs (%ID) and Standard Uptake Value (SUV);Radiation absorbed dose of target organs and whole-body effective dose;Adverse Event (AE), Serious Adverse Event (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive Percent Agreement (PPA) of 68Ga-EV203 PET/CT in Patients with Hematologic Malignancies;Positive Predictive Value Agreement (PPrA) (using 18F-FDG PET/CT imaging as a reference); | — |
Countries
China
Contacts
Public ContactYi Heqing
Zhejiang Cancer Hospital
Outcome results
None listed