68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: 68Ga-FAPI-FS PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI-FS PET/CT<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-FAPI-FS, PET/CT