68Ga-EV203: How the tracer spreads in the body and its safety in blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the biodistribution and dosimetry of a 68Ga-labeled tracer (EV203) using PET/CT in patients with hematological malignancies. It also assesses safety by recording adverse events and compares image quality across multiple time points after injection. The trial may include a comparison to 18F-FDG PET/CT to evaluate agreement in positive findings. Eligible participants are adults aged 18 to 75 who can lie still for 30 minutes and meet specific health criteria. The study is conducted at Zhejiang Cancer Hospital and led by the same institution.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Heqing Yi
• Email: yihq@zjcc.org.cn
• Phone: 0571-88122020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.