68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-FAPI-FS PET/CT 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.
|
Outcome Measures
Primary Outcome Measures
- Adverse events after injection of 68Ga-FAPI-FS [From tracer injection to 3 hour post-injection]
Adverse events will be recorded according to CTCEA v4.03
Secondary Outcome Measures
- SUVmax of liver on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The liver uptake will be measured using SUVmax with a 40% threshold.
- SUVmax of normal pancreas on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
- SUVmax of blood pool on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The blood pool uptake will be measured using SUVmax with a 40% threshold.
- SUVmax of lung on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The lung uptake will be measured using SUVmax with a 40% threshold.
- SUVmax of brain on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The brain uptake will be measured using SUVmax with a 40% threshold.
- SUVmax of muscle on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The muscle will be measured using SUVmax with a 40% threshold.
- SUVmax of tumor lesions on 68Ga-FAPI-FS [From study completion to 1 month after completion]
The tumor lesions will be measured using SUVmax with a 40% threshold.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
-
Expected survival of at least 3 months
-
ECOG ≤ 2
-
Written informed consent provided for participation in the trial
-
In the opinion of investigator, willing and able to comply with required study procedures.
Exclusion Criteria:
-
Pregnancy or breastfeeding.
-
Severe claustrophobia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Li Huo, MD, Peking Uion Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FAPI-FS