Diagnostic Performances of Ga-68-FAPI-46 PET in CRC Patients with Rising Serum CEA During the Post-treatment Surveillance
This single-center, phase II clinical trial investigates the diagnostic efficacy of Ga-68-FAPI-46 PET scans in detecting colorectal cancer (CRC) recurrence during post-treatment surveillance, particularly in patients with elevated serum carcinoembryonic antigen (CEA). The study compares the sensitivity, specificity, and accuracy of Ga-68-FAPI-46 PET with the conventional F-18-FDG PET scans, aiming to enhance recurrence detection in CRC patients who underwent curative surgery. Thirty participants will be enrolled and monitored through imaging studies and clinical follow-up.
• Age ≥ 20 years old
• The surgical intervention for colorectal cancer aims for curative resection, with the goal of achieving a disease-free status that persists for six months or more, as assessed clinically and through imaging studies.
• Elevated serum CEA levels:
⁃ Exceeding the laboratory's normal range (5 ng/ml) or, but not surpassing 13 ng/ml; using the individual's post-surgery +/- adjuvant chemotherapy or targeted therapy minimum value as a baseline, a consecutive increase of more than 10% for two times or as determined by the attending physician suggests suspicion of recurrence.
• Already performed or scheduled for FDG PET scanning examination. (5) Able to lie flat for at least 30 minutes.
• Signing the subject consent form.
• ECOG grade 0-2.
• The timing of F-18-FDG usage in this trial follows the 2023 - Colorectal Cancer Treatment Principles of our institution.