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A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

NCT07689656 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-08

No results posted yet for this study

Summary

Primary Objective:

To evaluate the safety and tolerability of PET imaging following a single intravenous infusion of \[⁶⁸Ga\]Ga-ELI421 injection in patients with prostate cancer.

Secondary Objectives:

To evaluate the biodistribution characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the radiation dosimetry characteristics of \[⁶⁸Ga\]Ga-ELI421 injection; To evaluate the diagnostic efficacy of PET imaging with \[⁶⁸Ga\]Ga-ELI421 injection.

Conditions

Interventions

DRUG

[68Ga]Ga-ELI421 injection

Administration Protocol: A single rapid intravenous bolus injection of \[68Ga\]Ga-ELI421 injection at a radioactivity dose of about 185 MBq (5 mCi), followed by catheter flushing with approximately 10 mL of 0.9% sterile normal saline. Static scanning and/or dynamic scanning Whole-body PET Imaging will be performed. PSMA PET imaging will be performed in accordance with routine clinical practice.

Sponsors & Collaborators

  • Eli Radiopharma

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-08
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07689656 on ClinicalTrials.gov