By InvitationEarly Phase 1

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

China18 participantsStarted 2026-06-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent obtained prior to the performance of any study-specific procedures. * Adults aged 18 years or older. * Histologically, cytologically, or clinically confirmed malignant solid tumor. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Clinical indication for \^18F-FDG PET imaging. * No clinically significant abnormalities in physical examination, vital signs, laboratory tests, or 12-lead electrocardiogram that, in the investigator's judgment, would interfere with study participation or image interpretation. * Women of childbearing potential must have a negative pregnancy test prior to administration of the investigational radiotracer. * Participants of childbearing potential (male and female) must agree to use highly effective contraception during the study and for at least 6 months after administration of the investigational radiotracer, and must refrain from sperm or oocyte donation during this period. * Willing and able to comply with all study procedures and follow-up requirements. Exclusion Criteria: * Any concomitant disease or medical condition that, in the investigator's judgment, could compromise participant safety or interfere with image interpretation. * Concomitant medications or therapies that may affect the safety, biodistribution, radiation dosimetry, or diagnostic performance of the investigational radiotracer. * Previous anticancer treatment (including chemotherapy, radiotherapy, immunoth…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is an early Phase 1 imaging trial, what does that mean for my safety — specifically, how much is known so far about any risks from the [68Ga]Ga-ELI411 radiotracer used in the PET scan?
2This trial is measuring something called SUV parameters on the PET scan — can you explain what that means for me, and whether the results from this scan would actually change or inform my treatment plan?
3Because enrollment is by invitation only, what criteria would make my doctors consider referring me for this study, and is there any reason my specific type of solid tumor would or wouldn't be a good fit?
4If I take part in this imaging study, does it delay or interfere with starting any standard treatments I might already be eligible for?
5Are there already approved PET imaging options for my tumor type, and how would participating in this experimental imaging trial compare to using one of those standard approaches instead?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET

Timeframe: 7 days

Trial details

NCT IDNCT07741006

SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Malignant Solid Tumor trials