Actively Recruiting
Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma
Led by Mayo Clinic · Updated on 2025-10-02
130
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 pancreatic ductal adenocarcinoma (PDA) that has not spread to other parts of the body (localized). 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 in large amounts. 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 scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional (3-D) views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. Giving 68Ga-FAPI-46 PET/CT may help doctors improve upon the diagnosis and management of PDA.
CONDITIONS
Official Title
Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years with treatment-naive, biopsy-confirmed pancreatic ductal adenocarcinoma or diagnostic findings on baseline imaging
- Localized pancreatic cancer expected to undergo surgical removal following neoadjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability to provide informed consent
You will not qualify if you...
- Known allergy or hypersensitivity to any component of 68Ga-FAPI-46
- Need for emergency surgery
- Biopsy showing non-pancreatic ductal adenocarcinoma tissue
- Proven metastatic pancreatic ductal adenocarcinoma
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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