GPC3-Targeted PET Imaging of 18F-X12 in Hepatocellular Carcinoma

Clinical Study of Glypican-3 (GPC3)-Targeted Novel Probe 18F-X12 for the Diagnosis of Hepatocellular Carcinoma (HCC)

This is a diagnostic study. This clinical trial aims to evaluate the diagnostic performance and safety of the novel radiotracer 18F-X12 in patients with hepatocellular carcinoma (HCC), and to provide evidence supporting a new approach for its early diagnosis, accurate staging and recurrence assessment.

Inclusion Criteria:

• Patients aged ≥ 18 years old.
• Patients fully understand the trial requirements, participate in the study voluntarily, and provide written informed consent.
• Meet either of the following two conditions:
• Patients with highly suspected hepatocellular carcinoma (HCC) (hepatic space-occupying lesion of undetermined nature on imaging examination) or pathologically confirmed HCC, with no prior systemic therapy (including immunotherapy, chemoradiotherapy, targeted therapy, etc.) or suspected tumor recurrence after previous treatment, and able to independently cooperate with relevant examinations.
• Patients with clinically diagnosed HCC who have received 18F-FDG positron emission tomography/computed tomography (PET/CT) for clinical staging or post-treatment restaging, and able to independently cooperate with relevant examinations.

Exclusion Criteria:

• Patients with severe non-malignant diseases that may interfere with study objectives, or impair subject safety and study compliance, including but not limited to psychiatric disorders, infectious diseases, autoimmune diseases, and metabolic diseases.
• Pregnant or lactating females.
• Subjects who are unable to understand the examination procedure or cannot cooperate with trial-related examinations and operations.