68Ga-GP-01 Injection in Solid Tumors Participants

Inclusion criteria

• Agreed to participate by providing a signed informed consent form and can comply with study-related procedures.
• Male or female aged ≥ 18 years old.
• Patients with solid tumors planned to undergo surgical resection or laparoscopic exploration and histopathology confirmation.
• Available CT/MRI images of suspected metastatic regions of cohort 1 patients; available CT/MRI images of both primary and metastatic regions of cohort 2 patients. .
• Be capable of receiving 18F-FDG PET/CT scan.
• Adequate renal function as determined by a creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
• Females of childbearing potential must have a negative pregnancy test.. Male and female participants of childbearing potential must use at least 2 highly effective forms of contraception, one of which must be a barrier method, or agree to remain abstinent for duration of study participation and for 3 months following Ga agent.

Exclusion criteria

• Any PET scan done within 10 physical half-lives of the PET agent prior to planned administration of 68Ga-GP-01.
• Exposure to any investigational agent within 4 weeks prior to the planned administration of 68Ga-GP-01.
• Major surgery, any systemic anti-cancer therapy or radiotherapy within 4 weeks prior to planned administration of 68Ga-GP-01.
• Past or current history of another malignancy, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years;
• Co-morbidities (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives.
• Planned antineoplastic therapies from time of consent to planned surgery or laparoscopic exploration.
• Planning to participate in any drug or device clinical trial during the study period.
• Has a known or suspected allergic reaction to any components of the formulation used in 68Ga-GP-01.
• Contraindications to PET/CT scan.
• Has a medical, psychological, or social condition that, in opinion of the investigators will make it difficult to comply study procedures.
• Female participants who are pregnant or lactating.
• Other reasons determined by investigators.