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Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors

NCT07741006 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-08-03

No results posted yet for this study

Summary

This is a prospective, single-center, open-label, two-cohort clinical study evaluating the safety, tolerability, biodistribution, radiation dosimetry, and diagnostic performance of \[68Ga\]Ga-ELI411 PET imaging in adult patients with solid tumors. Eligible patients with an indication for 18F-FDG PET imaging will receive a single intravenous administration of \[68Ga\]Ga-ELI411 followed by serial PET imaging. Imaging findings will be compared with conventional imaging, histopathology, and clinical follow-up when applicable. The study will also evaluate tracer biodistribution, radiation dosimetry, and lesion detection performance compared with standard 18F-FDG PET imaging.

Conditions

  • Malignant Solid Tumor

Interventions

DRUG

[68Ga]Ga-ELI411

For Cancer patients, subjects should have target FAP protein.

Sponsors & Collaborators

  • 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-28
Primary Completion
2027-04-30
Completion
2027-05-30

Countries

  • China

Study Locations

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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 NCT07741006 on ClinicalTrials.gov