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

Enrolling by invitation · Early Phase 1

Conditions studied: Malignant Solid Tumor

In brief

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.

Key facts

Study ID

NCT07741006

Run by

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

People needed

18

Starts

2026-06-28

Expected to finish

2027-05-30

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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, immunotherapy, targeted therapy, radionuclide therapy, or major surgery) without an adequate washout period, as determined by the investigator.
• Known hypersensitivity to gallium-containing radiopharmaceuticals, ethanol, any component of the investigational product, or a history of severe allergic reactions.
• Pregnant or breastfeeding women.
• Inability to undergo PET/CT imaging or comply with study procedures. Participation in another interventional clinical trial that, in the investigator's judgment, could interfere with this study.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Where it is running

• Union Hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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