NCT05875753

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-05-25
• Last updated: 2023-05-25

Locations

1 site across 1 country: China