NCT07741006Enrolling By InvitationPhase 1
A Single-Center, Prospective, Open-Label, Two-Cohort Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Diagnostic Performance of [68Ga]Ga-ELI411 PET Imaging in Chinese Adult Patients With Solid Tumors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology1 site in 1 country18 target enrollmentStarted: June 28, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Outcomes
Primary Outcomes
Semiquantitative SUV Parameters of Lesions on [68Ga]Ga-ELI411 PET
Time Frame: 7 days
Semiquantitative imaging metrics measured from \[68Ga\]Ga-ELI411 PET lesions（SUVmax of target lesions）.
Secondary Outcomes
- Semiquantitative imaging metrics of Lesions on [68Ga]Ga-ELI411 PET(7 days)
Investigators
Study Sites (1)
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