The aim of the project is to demonstrate superior detection ratio of \[18F\]AlF-FAPI-74 PET/CT compared to \[18F\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \[18F\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.
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.
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).
Single group
[18F]AlF-FAPI-74 PET/CT
Diagnostic testA \[18F\]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the \[18F\]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second \[18F\]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second \[18F\]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) \[18F\]AlF-FAPI-74 PET/CT, before the final surgery.
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Detection ratio for lymph node and distant metastases (combined).
Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)
Detection ratio for lymph node and distant metastases (combined).
Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
Fraction of patients were scan was deemed contributory. This means: 1. \[18F\]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. \[18F\]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. \[18F\]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.
OGA & PDAC: Detection ratio for tumor detection
primary tumor alone; lymph nodes alone (N-staging); distant metastases alone (M-staging) and lymph node + distant metastases combined (with inclusion of patients without N- or M-lesions).
OGA & PDAC: specificity, positive and negative predictive value and accuracy
Specificity, positive predictive value, negative predictive value, accuracy for lymph node and distant metastases (combined); for detection of primary tumor; for lymph nodes alone (N-staging); for distant metastases alone (M-staging).
OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
Positive and negative likelihood ratios; diagnostic odds ratio.
OGA & PDAC: semi-quantitative uptake measurements
Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on \[18F\]AlF-FAPI-74 PET/CT and \[18F\]FDG PET/CT.
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KU Leuven
Lead sponsor
University Hospital, Ghent
Collaborator
University Hospital, Antwerp
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Kom Op Tegen Kanker
Collaborator
