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

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.