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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: Pancreatic Cancer

Treatments: Diagnostic Test: 68Ga-FAPI-FS PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05875753

FAPI-FS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

68Ga-FAPI-FS PET/CT

Experimental group

Description:

Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Treatment:

Diagnostic Test: 68Ga-FAPI-FS PET/CT