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

Launched by SOFIE · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a special type of PET scan called \[18F\]FAPI-74, which helps doctors detect certain cancer cells in patients with gastrointestinal cancers. These cancers include liver cancer, bile duct cancer, stomach cancer, pancreatic cancer, and colorectal cancer. The goal is to see how well this PET scan can find cancer compared to other traditional methods that look at tissue samples obtained from biopsies or surgeries. If you're diagnosed with one of these cancers and have not started treatment yet, you might be eligible to participate in this study.

To join, participants must be at least 18 years old and have a confirmed diagnosis of gastrointestinal cancer. They should also have a tissue sample available from a biopsy or surgery, and no treatment should have been given between the sample collection and the PET scan. During the study, participants will undergo the PET scan and have their results compared with the tissue samples to help determine how effective the scan is. It's important to note that certain conditions, such as being pregnant or having serious health issues, may prevent someone from participating. This trial is currently recruiting participants, and taking part in it could help improve future cancer detection methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
• • Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy 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 for individuals of child-bearing potential
• • Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
• • Need for emergent surgery that would be delayed by participation
• • Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to 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 diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
• • Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in 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 participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[18F\]FAPI-74 injection
• • Known hypersensitivity to any excipients used in \[18F\]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
• • Renal or liver function impairment\* \*Defined by liver impairments as AST\>3x the upper limit of normal, ALT\>3x the upper limit of normal, or bilirubin\>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of \>1.5x the upper limit of normal utilizing the Cockcroft Gault formula