MedTrace Logo

Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies

NCT07670949 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-26

No results posted yet for this study

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 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

  • Hematological Malignancies B

Interventions

DIAGNOSTIC_TEST

68Ga-EV203 PET/CT

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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-06-01
Completion
2029-06-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670949 on ClinicalTrials.gov