Project title: Development of a Low Molecular Weight Fluorine-18 FAPI Imaging Agent and Companion Radiotherapeutic

Benjamin Viglianti, MD, PhD The University of Michigan

Benjamin Viglianti, MD, PhD
  • Status: Active
  • Year(s): 2023
  • Grant Type: Investigator
  • Research Type: Translational
  • Primary Tumor Site: Multiple

Project Description:

Dr. Viglianti and his team (Drs. Brooks, Scott, Forsberg, and Kulkarni) will develop and test a new low molecular weight F-18 labeled fibroblast activation protein inhibitor (FAPI) that can be labeled with therapeutic isotopes: I-131 or At-211. They will test this diagnostic agent along with Ga-68 FAPI-04 in patients with neuroendocrine tumors that cannot be sufficiently imaged with PET using somatostatin receptor (SSTR) targeting radiopharmaceuticals like Ga-68 DOTATATE. 

What critical NET problem will you try to solve through your research?

This project will focus on 3 challenges: 1) maximizing tumor-to-background uptake of the radiolabeled FAPI agents by utilizing lower molecular weights to increase normal tissue clearance, 2) determining the ability of FAPI-based agents to image and potentially treat NETs that have low or absent somatostatin receptor (SSTR) expression, thus not allowing standard-of-care SSTR-targeted peptide receptor radionuclide therapy (PRRT), and 3) demonstrating the advantage of Total Body PET/CT for lesion detection. 

Why is this important? 

This research aims to address an unmet need in patients who do not qualify for standard PRRT due to their tumor’s lack of SSTR expression. FAP is a promising target, which is overexpressed in the tumor microenvironment of more aggressive tumors, such as high-grade NETs and neuroendocrine carcinomas. Additionally, the development of an improved FAPI agent can also benefit patients with many other tumor types that express FAP. 

What will you do as part of this research project?

Dr. Viglianti will coordinate the project, running the overall clinical trial and analyzing the collected data. Dr. Forsberg and Dr. Kulkarni will be responsible for overseeing the portion of the clinical trial at BAMF Health. Finally, Dr. Brooks and Dr. Scott will be responsible for the radiochemistry of both the F-18 FAPI agent and Ga-68 FAPI-04. 

How might your research improve the diagnosis and/or treatment of NETs? 

This research will demonstrate that FAPI can be used to diagnose and potentially treat NET patients who are not candidates for PRRT, thereby offering a promising theranostic option for these patients. Additionally, this work will also establish the foundation of possible combined FAP and SSTR-targeted therapies in NET patients by investigating the relative presence of these tumor targets. 

What is your next step? 

Our immediate next step is to obtain final approval/IND to test our F-18 FAPI agent and begin patient accrual to evaluate Ga-68 FAPI-04 in NET patients with insufficient tumor SSTR expression. 


Additional Details

  • City: Ann Arbor
  • State: MI
  • Country: United States
  • Grant Duration: 2


NETRF funds laboratory research to understand the development of neuroendocrine tumors and translational research to explore new concepts in treatment. Research grant descriptions and research updates from NETRF are not intended to serve as medical advice. It can take years for research discoveries to be fully validated and approved for patient care. Always consult your health care providers about your treatment options.

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