Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Phase EARLY_PHASE1
Started
2026-06-28
Last updated
2026-08-03
Condition(s) studied
Malignant Solid Tumor
Investigational drug(s) / intervention(s)
[68Ga]Ga-ELI411
[68Ga]Ga-ELI411: For Cancer patients, subjects should have target FAP protein.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, 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.
Primary outcome measure(s)
Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET — 7 days Semiquantitative imaging metrics measured from \[68Ga\]Ga-ELI411 PET lesions(SUVmax of target lesions).
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Huazhong University of Science and Technology
Wuhan
Hubei
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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