PET imaging of tumors with strong desmoplastic reaction in pancreas, bile ducts, ventricle and ovaries by a novel tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor

Cancer

Surgery with histopathological confirmation of diagnosis

To evaluate FAPI- PET/CT as a staging tool for all included cancer entities, the secondary endpoint variables will be assessed with the histopathological diagnosis as a refence standard for regional or distant lymph nodes and/or resected local or distant metastatic tumor tissue when present., To investigate the correlation between in-vivo uptake of FAPI and ex-vivo immunohistochemically determined biomarker (FAP, PDGFR-α, PDGFR-β and α-SMA) expression in the stroma of these tumors, postsurgical histopathological confirmation of diagnosis will be used for confirmation of tumor histology (benign and malignant)., Assessment of FAPI- PET/CT and stroma markers as prognostic factors in patients with these cancers will be performed by recording disease free survival (DFS) and overall survival OS at 1 – year, 2 – years and 5 – years clinical follow – ups continuously during the follow – up period of the study., 4. To investigate the difference in diagnostic accuracy of FAPI- PET/CT compared to conventional radiology performed according to clinical routine, either postsurgical histopathological or histopathological/cytological (in the case of tissue biopsy material) confirmation of diagnosis will be used as a reference standard for differential diagnosis between malignant and benign lesions as well as for N and M staging, To investigate the frequency of Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)

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Finland, Sweden