Enrolling by invitation
Early Phase 1
Clinical Evaluation of [68Ga]Ga-ELI411 PET Imaging in Adult Patients With Solid Tumors
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
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
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