NCT05518903

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

Recruiting now Phase 2 Last updated 2 October 2025

What this trial tests

Phase 2 trial testing Computed Tomography in Localized Pancreatic Adenocarcinoma in 130 participants. Currently enrolling.

Timeline

15 November 2022

Primary endpoint
30 June 2027

30 June 2028

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	130
Start date	15 November 2022
Primary completion	30 June 2027
Estimated completion	30 June 2028
Sites	1 location across United States

Drugs / interventions tested

• Computed Tomography
• Gallium Ga 68 FAPi-46 — full drug profile →
• Positron Emission Tomography

Conditions studied

• Localized Pancreatic Adenocarcinoma — all drugs for Localized Pancreatic Adenocarcinoma →
• Resectable Pancreatic Ductal Adenocarcinoma — all drugs for Resectable Pancreatic Ductal Adenocarcinoma →
• Stage 0 Pancreatic Cancer AJCC v8 — all drugs for Stage 0 Pancreatic Cancer AJCC v8 →
• Stage I Pancreatic Cancer AJCC v8 — all drugs for Stage I Pancreatic Cancer AJCC v8 →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Localized Pancreatic Adenocarcinoma or Resectable Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. From basic research to clinical application: targeting fibroblast activation protein for cancer diagnosis and treatment.
   Zhang Z, Tao J, Qiu J, Cao Z, et al · · 2024 · cited 21× · PMID 37726505 · DOI 10.1007/s13402-023-00872-z
2. Theranostics in targeting fibroblast activation protein bearing cells: Progress and challenges.
   Rezaei S, Gharapapagh E, Dabiri S, Heidari P, et al · · 2023 · cited 17× · PMID 37481033 · DOI 10.1016/j.lfs.2023.121970
3. Cancer-Associated Fibroblasts in Pancreatic Ductal Adenocarcinoma or a Metaphor for Heterogeneity: From Single-Cell Analysis to Whole-Body Imaging.
   Saúde-Conde R, Arçay Öztürk A, Stosic K, Azurmendi Senar O, et al · · 2024 · cited 13× · PMID 38540204 · DOI 10.3390/biomedicines12030591
4. Comparison of early and late ⁶⁸Ga-FAPI-46-PET in 33 patients with possible recurrence of pancreatic ductal adenocarcinomas.
   Hoppner J, van Genabith L, Hielscher T, Heger U, et al · · 2023 · cited 13× · PMID 37857656 · DOI 10.1038/s41598-023-43049-2
5. Fibroblast activation protein targeting radiopharmaceuticals: From drug design to clinical translation.
   Wu Y, Wang X, Sun X, Gao X, et al · · 2025 · cited 7× · PMID 41049753 · DOI 10.1016/j.apsb.2025.07.009
6. Cancer-Associated Fibroblasts: Origin, Classification, Tumorigenicity, and Targeting for Cancer Therapy.
   Fan C, Zhu W, Chen Y, Zhu W, et al · · 2025 · cited 4× · PMID 41164803 · DOI 10.1002/mco2.70415
7. The role of cancer-associated fibroblasts in the tumour microenvironment of urinary system.
   Hong R, Yu P, Zhang X, Su P, et al · · 2025 · cited 4× · PMID 40195290 · DOI 10.1002/ctm2.70299
8. Emerging role of cancer-associated fibroblasts in the premetastatic niche.
   Yang S, Guo Y, Jia J, Cui W, et al · · 2025 · cited 3× · PMID 41063157 · DOI 10.1186/s12943-025-02461-0