(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Pancreatic cancer | Bile duct cancer | Gastric cancer | Epithelial ovarian cancer

Inclusion criteria

• {"criterion_text":"- 1.\tThe subject has given written consent to participate in the study\n- 2.\tThe subject has suspected pancreatic, gastric, biliary or epithelial ovarian cancer based on multimodal strategy including markers in blood, markers in tissue and imaging diagnostics; scheduled for surgical removal of this lesion with histopathological confirmation of diagnosis."}

Exclusion criteria

• {"criterion_text":"- Age ≤18 year\n- Pregnancy and lactation\n- Known metastatic disease (Not applicable for the EOC study group as most cases are already metastasized at the point of primary diagnosis)\n- Significantly reduced renal function\n- Allergy to iodinated contrast media\n- Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment"}

Primary endpoints

• {"endpoint_text":"- Surgery with histopathological confirmation of diagnosis","definition_or_measurement_approach":"Histopathological confirmation of diagnosis after surgery"}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessment against histopathological diagnosis as reference standard for regional or distant lymph nodes and/or resected local or distant metastatic tumor tissue when present."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Correlation analysis between in-vivo FAPI uptake and ex-vivo immunohistochemically determined biomarkers (FAP, PDGFR-α, PDGFR-β and α-SMA); postsurgical histopathological confirmation used to confirm tumor histology."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Recording of disease-free survival (DFS) and overall survival (OS) at 1-, 2- and 5-year clinical follow-ups during study follow-up period."}
• {"endpoint_text":"- 4.\tTo 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","definition_or_measurement_approach":"Comparison of diagnostic accuracy of FAPI-PET/CT vs conventional radiology using postsurgical histopathological or histopathological/cytological confirmation as reference standard for differential diagnosis (benign vs malignant) and N/M staging."}
• {"endpoint_text":"- To investigate the frequency of Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)","definition_or_measurement_approach":"Recording and frequency analysis of AEs, ARs, SAEs and SUSARs."}

Methods

• All consecutive patients scheduled for surgical removal of either a pancreatic, biliary, or gastric lesion during a 3-year period (2021-2024) will be informed about this study and included after signed informed consent.
• All consecutive patients scheduled for primary surgical removal of early stage EOC, interval debulking surgery (IDS) of EOC or surgical removal alternatively tissue biopsy of recurrent EOC during a 2-year period (2022-2024) will be informed about this study and included after signed informed consent.

Sweden

Earliest CTIS Part Ii Submission Date

30-05-2024

Latest Decision Or Authorization Date

13-05-2025

Processing Time Days

348

Number Of Sites

1

Number Of Participants

410

Finland

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

25

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"The Cancer Research Funds of Radiumhemmet (Radiumhemmets Forskningsfonder)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"The Swedish Cancer Society (Cancerfonden)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Region Stockholm (Stockholm County Council)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"The Sjöberg Foundation (Sjöbergstiftelsen)","duties_or_roles":"Source of monetary support","organisation_type":""}