Study of [18F]FAPI-74 PET in Patients with Gastrointestinal Cancers

Inclusion Criteria:

• Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellularcarcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer

• Available tissue sample obtained through biopsy or to be obtained through scheduledbiopsy and/or surgical resection

• No treatment received between tissue sample taken and [18F]FAPI-74 PET

• Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent

• Age ≥ 18 years

• Completed informed consent as determined per the IRB of record

Exclusion Criteria:

• Pregnant as determined by a pregnancy test as per institutional guidelines forindividuals of child-bearing potential

• Declining to use effective contraceptive methods during the study (for individualsof child-producing potential)

• Need for emergent surgery that would be delayed by participation

• Bacterial, viral, or fungal infections requiring systemic therapy, that are expectedto impact FAP expression in the opinion of the sponsor or their designee

• Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis,kidney failure, liver failure, systemic or local inflammatory or autoimmune diseasesor other conditions) that in the opinion of the investigator, physician of recordand/or Sofie could compromise subject safety and/or protocol objectives

• Known diagnosis of an autoimmune disorder that is expected to impact FAP expressionin the opinion of the sponsor or their designee

• Patients receiving any other investigational agent within the past 28 days

• Breastfeeding. Note: nursing parents are allowed if the potential participantcommits to pumping breast milk and discarding it from injection to ≥ 24 hours fromthe time of the [18F]FAPI-74 injection

• Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts ofsodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.

• Renal or liver function impairment* *Defined by liver impairments as AST>3x theupper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upperlimit of normal. Renal impairment as defined by a creatinine clearance of >1.5x theupper limit of normal utilizing the Cockcroft Gault formula