Background:
Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.
Objective:
To see if \[18F\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers.
Eligibility:
People aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer.
Design:
Participants will have 2 baseline scans: an \[18F\]FAPI-74, and the approved tracer \[18F\]-FDG.
The \[18F\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging.
Within 1 week, participants will undergo the same scanning procedures with the approved tracer.
If the baseline scan with \[18F\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scan. If \[18F\]-FAPi PET scan shows no tumor(s), scans will not be repeated.
If the participant's cancer progresses within 2 years, scans may be repeated.
Follow-up calls will continue for 2 years.
Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.
Participants must be scheduled or intended to receive treatment for their cancer.
Evaluable disease
>= 18 years old.
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.
Parallel
[18F]FAPI-74
DrugParticipants will receive a single intravenous (IV) dose of \[18F\]FAPI-74 prior to PET/CT imaging.
[18F]FDG
Drug18F-FDG PET/CT or PET/MRI imaging will be done per standard of care.
Mean number of lesions
The mean number of lesions detected will be compared between the different scan modalities for each cancer type.
Standardized uptake value
For \[18F\]FAPI-74 PET imaging positive participants who undergo treatment, the change in \[18F\]FAPI-74 PET imaging uptake (SUV) between treatment will be compared by paired signed-rank Wilcoxon test. Response to treatment evaluated by \[18F\]FAPI-74 PET imaging will be compared with a response based on RECIST 1.1 and 18F-FDG PET by Fisher's exact test.
Safety of [18F]FAPI 74 PET imaging
Safety will be evaluated by determining the frequency of adverse events among participants and reporting the results, by maximum grade of event and type of toxicity noted.
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