Malignant Solid Tumor
Conditions
Keywords
FAP, Fibroblast Activation Protein, PET, Solid Tumor
Brief 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.
Interventions
DRUG[68Ga]Ga-ELI411
For Cancer patients, subjects should have target FAP protein.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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）. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET | 7 days | Semiquantitative imaging metrics (tumor-to-background ratios) of \[68Ga\]Ga-ELI411 PET lesions |
Countries
China
Outcome results
None listed