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

Early Phase 1

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: 68Ga-FAPI-FS PET/CT

• Registration Number: NCT05875753
• Lead Sponsor: Peking Union Medical College Hospital

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.

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 Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-25
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Written informed consent provided for participation in the trial
5. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria

1. Pregnancy or breastfeeding.
2. Severe claustrophobia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-FS PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China