A Study to Evaluate the Safety and Diagnostic Performance of F18 FBPA PET/CT Imaging in Solid Tumors

Inclusion criteria

• Subject aged 18-80 (inclusive).
• Histopathological confirmed diagnosis of a solid tumor (including but not limited to osteogenic sarcoma, brain tumors, head and neck cancer, lung cancer, breast cancer, or colorectal cancer).
• At least one measurable lesion identified on prior imaging evaluation, assessed by RECIST version 1.1.
• Willingness to undergo PET/CT scan.
• Provision of signed informed consent.

Exclusion criteria

• Body weight > 80 kg at screening.
• Any contraindication to PET, including active breastfeeding. Female subjects of reproductive potential must have a negative serum pregnancy test at screening.
• History of claustrophobic reactions.
• History of phenylketonuria.
• History of research-related radiation exposure exceeding the Nuclear Safety Commission's current guideline of 50 mSv within the past 12 months.
• Inability to lie comfortably in a supine position for more than 60 minutes.as assessed by physical examination and medical history (e.g., back pain, severe arthritis).
• Subjects from other at-risk populations, including minors, cognitively impaired individuals.
• Suspected or known hypersensitivity (including allergy) to any F18 FBPA components or contrast media
• Hereditary fructose intolerance.
• A greater risk than normal for potential cardiac arrest such as history of non-compensated congestive heart failure, poorly controlled arrythmias or symptomatic non compensated cardiopathies.
• Inadequate organ function within 30 days prior to the F18 FBPA PET/CT, defined as:

QTc > 460 msec; Serum Albumin < 2.8 mg/mL; Total Bilirubin > 3.0 mg/mL; ALT ≥ 400 U/L and/or AST ≥ 400 U/L; Creatinine < 0.5 mg/dL or > 1.4 mg/dL; eGFR < 60 mL/min/1.73 m2

• Any medical or psychiatric conditions under the supervision of the investigator may interfere with optimal participation in the study or place the subject at increased risk of AEs.
• History of radiation therapy within 3 months prior to the screening visit.
• History of renal impairments, including nephrolithiasis, nephrotic syndrome, or hematuria, and/or other severe renal conditions in the opinion of the investigator.