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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-FAPI-FS PET/CT | Experimental | Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI-FS PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events after injection of 68Ga-FAPI-FS | Adverse events will be recorded according to CTCEA v4.03 | From tracer injection to 3 hour post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| SUVmax of liver on 68Ga-FAPI-FS | The liver uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of normal pancreas on 68Ga-FAPI-FS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Huo, MD | Contact | 18612672038 | huoli@pumch.cn | |
| Wenjia Zhu, MD | Contact | 18614080164 | zhuwenjia_pumc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Huo, MD | Peking Uion Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
| 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. | 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. | 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. | 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. | 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. | From study completion to 1 month after completion |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |