The National Cancer Institute (NCI) has awarded Mayo Clinic (Rochester), in partnership with SOFIE, a five-year R01 clinical trial, “Quantitative In Vivo 68Ga-Fibroblast-Activation-Protein-Inhibitors (FAPI)-46 PET Imaging of Cancer-Associated Fibroblasts (CAFs) in Pancreatic Ductal Adenocarcinoma (PDA).”

The $3.3 million grant will enable the research team, led by principal investigator Ajit H. Goenka, M.D., an Abdominal Imaging and Nuclear Medicine radiologist, to undertake clinical investigation of [68Ga]FAPI-46 as a novel radiotracer in pancreatic cancer in an investigator-initiated trial.

Fibroblast activation protein (FAP)-expressing cancer-associated fibroblasts (CAFs) play a central role in the pancreatic cancer’s aggressiveness. [68Ga]FAPI-46  has emerged as a positron emission tomography (PET) radiotracer with optimal properties for fibroblast activation protein-targeted imaging and therapy in pancreatic cancer. In this investigator-initiated trial, the team seeks to address the unmet clinical needs in pancreatic cancer as well as to improve understanding of disease biology. The investigator-initiated study as part of the grant will be in addition to the SOFIE sponsored trial, which is a phase 2, multicenter, study of [68Ga]FAPI-46 PET in patients with resectable or borderline resectable PDA (NCT05262855).

Trevor Subero, SOFIE’s Senior Vice President, Business Development, commented, “this partnership between SOFIE and Mayo Clinic draws on the strengths of both parties to achieve a robust clinical study. We look forward to working with our academic colleagues in further exploring the capabilities of FAPI PET imaging.”

[68Ga]FAPI-46 will be produced at Mayo Clinic’s PET radiochemistry lab with SOFIE providing a generator and its proprietary radiotracer synthesis method to Mayo to help in on-site production of the radiotracer. The Mayo Investigational New Drug (IND) has been obtained through a letter of cross reference to SOFIE’s active [68Ga]FAPI-46 IND.