FAPI in Rectal Cancer TNT

Inclusion criteria

• Biopsy proven newly detected adenocarcinoma of the rectum
• Clinical stage II-III rectal cancer
• Aged at least 18 years. No upper age limit.
• WHO/ECOG Performance Status 0-1
• Eligible for total neoadjuvant therapy

Exclusion criteria

• Distant metastases found on either CT, MR or FDG-PET
• Prior anticancer therapy for colorectal cancer
• Prior radiotherapy of the pelvic region
• Other concurrent antineoplastic therapy
• Major surgery within the last 4 weeks prior to inclusion
• Subjects pregnant or breast feeding
• Serious concurrent diseases not compatible with study entry, including active, uncontrolled infections, active, disseminated coagulation disorder, clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia within 6 months before enrolment)
• Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression
• Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1)
• Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline
• Those deemed unsuitable for participation in the trial by the investigators.