18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method using a special substance called 18F-FAPI-74 to help detect certain types of cancer more effectively. The goal is to find out if this new tracer can better highlight cancerous tumors in the pancreas, liver, gallbladder, stomach, bladder, ovaries, and adrenal glands compared to currently approved methods. To participate, individuals must be 18 years or older and have a confirmed diagnosis of specific cancers while also being part of another treatment study at the NIH.

Participants in the trial will have two initial scans: one using the new tracer and another using a standard tracer. After receiving the new tracer through an injection, they'll undergo imaging about an hour later. If the new method shows tumors, follow-up scans will be scheduled as part of their regular treatment. Throughout the study, participants will also receive follow-up calls for two years to monitor their progress. It’s important for potential participants to understand the eligibility requirements and be willing to follow safety guidelines during the study.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma, small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.
• • Participants must be co-enrolled in an NIH parent cancer treatment clinical trial with planned evaluation of response per RECIST v.1.1 and other imaging considered standard of care (SOC).
• • Evaluable disease
• • \>= 18 years old.
• • Eastern Cooperative Oncology Group (ECOG) performance score \<= 2.
• • Individuals of child-bearing potential (IOCBP) and individuals that can father children must agree to use effective contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) at the study entry and for 2 months after each \[18F\]FAPI-74 imaging. Sperm may not be frozen or donated within the same period.
• • Must be willing to discontinue breastfeeding for 2 months after each study imaging.
• • The ability of participant to understand and the willingness to sign a written informed consent document.
• EXCLUSION CRITERIA:
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[18F\]FAPI-74 or other agents used in the study.
• • History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.
• • Weight \> 350 lbs., or inability to fit within the imaging gantry.
• • Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
• • Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.
• • Serum creatinine \> 2 times the upper limit of normal.
• • Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.