[18F]FAPI-PET/CT and Laparoscopy in STagIng advanced gastric Cancer – a multicenter prospective study (PLASTIC-3-study)

Advanced gastric cancer

Proportion of patients in whom [18F]AlF-FAPI-74 PET/CT leads to detection of M1-disease resulting in change in treatment intent determined by the local multidisciplinary team (MDT) meetings, including: the number of prevented unnecessary surgeries (staging laparoscopies and/or gastrectomies) and the number of changes from curative to palliative treatment, Proportion of patients in whom [18F]AlF-FAPI-74 PET/CT leads to changes in diagnostic work-up determined by the local MDT meetings, including: the number of additional biopsies or longitudinal imaging and the number of changes in extent of surgery

Diagnostic performance measured in sensitivity, specificity, diagnostic accuracy, positive predictive value and negative predictive value using histopathologic tumor tissue collected during biopsy, staging laparoscopy and follow-up imaging as refence test, Proportion of patients with relevant incidental findings (e.g. second primary tumors), Patients’ extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using EORTC-QLQ-C30, EQ-5D-5L, and patient reported experience measure (PREM) questionnaires (section 6.1), Time between pre-diagnostic and post-diagnostic MDT meetings, The occurrence, type, and severity of (serious) adverse events, Correlation between 18F]AlF FAPI 74 PET based Peritoneal Cancer Index (PCI) scores and staging laparoscopy based PCI scores as a reference standard for ‘true’ intraperitoneal tumor load, Correlation between PCI-regional FAPI uptake and PCI-regional histopathological tumor scores, Expression of CAF content as measured by tumor-stroma ratio (TSR) on tissue samples from D1D2/CRITICS and relation with FAP expression., Analysis of TSR and FAP expression and correlation to [18F]AlF-FAPI-74 PET/CT signal, Analysis of all FAP expressing CAF subsets in obtained patient samples using imaging mass cytometry, Patient burden using a developed patient reported experience measure (PREM) questionnaire, Quality of life as measured using the EORTC-QLQ-C30 and EQ-5D5L questionnaires and compared to PLASTIC, Costs of [18F]AlF- FAPI-74 PET/CT compared with staging laparoscopy compared to PLASTIC for patients who received SL only, using the SL bottom-costing approach numbers from the PLASTIC-cost analysis study

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