Overview

An Investigational Scan (68Ga-FAPI-46 PET/CT) for the Imaging of Cancer-Associated Fibroblasts in Patients With Localized Pancreatic Ductal Adenocarcinoma

Status:
Not yet recruiting
Trial end date:
2028-06-30
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts (CAFs) in patients with localized (has not spread to other parts of the body) pancreatic ductal adenocarcinoma (PDA). CAFs are a type of connective tissue cell that are found within or near cancerous tissue. Many CAFs express a protein called fibroblast activation protein (FAP) that are not found on healthy cells. 68Ga-FAPI-46 is a radioactive chemical compound designed to circulate through the body and attach itself to FAP on PDA cells. A PET/CT scan is then used to detect the location of FAP lesions. PET scans help to measure the information about functions of tissues and organs within the body. CT scans use X-rays to create images of the bones and internal organs within the body. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
FAPI-46
Criteria
Inclusion Criteria:

- Adults > 18 years (yrs.) with treatment-naive biopsy-proven PDA or with findings
diagnostic for PDA on baseline imaging (CT, MRI, or PET)

- Localized disease expected to undergo surgical resection following neoadjuvant therapy
(NAT)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Ability to provide informed consent

Exclusion Criteria:

- Hypersensitivity to any excipients in 68Ga-FAPI-46

- Require emergency surgery

- Non-PDA histology on biopsy

- Histopathologically proven metastatic PDA

- Pregnant women