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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875753
• Other study ID #: FAPI-FS
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: Li Huo, MD
• Phone: 18612672038
• Email: huoli[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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