This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution, and tumor uptake of 68Ga-FAPI-FS.
This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Participants will be administered a single, intravenous bolus of 68Ga-FAPI-FS. The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-FAPI-FS administration.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGAdverse events after injection of 68Ga-FAPI-FS
Adverse events will be recorded according to CTCEA v4.03
Time frame: From tracer injection to 3 hour post-injection
SUVmax of liver on 68Ga-FAPI-FS
The liver uptake will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of normal pancreas on 68Ga-FAPI-FS
The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of blood pool on 68Ga-FAPI-FS
The blood pool uptake will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of lung on 68Ga-FAPI-FS
The lung uptake will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of brain on 68Ga-FAPI-FS
The brain uptake will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of muscle on 68Ga-FAPI-FS
The muscle will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
SUVmax of tumor lesions on 68Ga-FAPI-FS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The tumor lesions will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion