An Early Phase 1 interventional study of 68Ga-FAPI-FS PET/CT in Pancreatic Cancer, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Diagnostic
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.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 50 is close to the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Diagnostic Test: 68Ga-FAPI-FS PET/CT
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.
Adverse 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
The tumor lesions will be measured using SUVmax with a 40% threshold.
Time frame: From study completion to 1 month after completion
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jun 2024, 24 months after the start.
Of 186 non-industry phase 1 interventional studies under Pancreatic Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 75. This study's planned 24 months is below that.
Counting every sponsor, half of 293 studies reached it within 46 months; a quarter within 34 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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