Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types

Inclusion criteria

• GA:
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• Age 18 or older.
• New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
• Patient underwent a \[18F\]FDG PET/CT.
• TNM classification: cT1-4N0-3M0
• Inclusion Criteria PDAC:
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• Age 18 or older.
• New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
• Patient underwent a \[18F\]FDG PET/CT or conventional staging with CT or MRI.
• TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.
• Inclusion Criteria Clinically challenging cohort:
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• Age 18 or older.
• Histologic or cytologic proven diagnosis of a malignancy.
• Patient underwent a \[18F\]FDG PET/CT.
• Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion criteria

• Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
• Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
• Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
• Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
• Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
• Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.