[AL[18F]F]FAPI-74 for Advanced gastric cancer

Inclusion criteria

• {"criterion_text":"- Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy\n- Age greater than or equal to 18 years\n- Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making\n- Patients must have given written informed consent\n- Patients who have recently participated in an interventional study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period)"}

Exclusion criteria

• {"criterion_text":"- Siewert type I-II esophagogastric junction tumor\n- Unfit or unwilling to undergo study procedures\n- Unfit or unwilling to undergo surgery\n- Pregnancy at time of the [18F]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden\n- Incapacitated subjects without decision-making capacity\n- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent\n- Illiterate patients unable to complete the resource use and quality of life questionnaires\n- Inability to undergo PET/CT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes)"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Determined by local multidisciplinary team (MDT) meetings; measured as the proportion of patients where PET/CT detection of M1 disease results in change in treatment intent, including counts of prevented unnecessary surgeries and changes from curative to palliative treatment."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Determined by local MDT meetings; measured as the proportion of patients with changes in diagnostic work-up (additional biopsies, longitudinal imaging, changes in extent of surgery) attributable to PET/CT findings."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured using histopathologic tumor tissue collected during biopsy, staging laparoscopy and follow-up imaging as reference standard; performance metrics include sensitivity, specificity, diagnostic accuracy, PPV, NPV."}
• {"endpoint_text":"- Proportion of patients with relevant incidental findings (e.g. second primary tumors)","definition_or_measurement_approach":"Measured as the proportion of patients with relevant incidental findings identified on PET/CT (e.g., second primary tumors)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Patient-reported outcome measures: EORTC-QLQ-C30, EQ-5D-5L, and PREM questionnaires to assess extra burden from additional diagnostics."}
• {"endpoint_text":"- Time between pre-diagnostic and post-diagnostic MDT meetings","definition_or_measurement_approach":"Measured as time interval between pre-diagnostic and post-diagnostic MDT meetings."}
• {"endpoint_text":"- The occurrence, type, and severity of (serious) adverse events","definition_or_measurement_approach":"Standard adverse event reporting; occurrence, type and severity recorded according to study safety procedures."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Correlation analysis between PET-based PCI scores and staging laparoscopy PCI scores (laparoscopy as reference standard)."}
• {"endpoint_text":"- Correlation between PCI-regional FAPI uptake and PCI-regional histopathological tumor scores","definition_or_measurement_approach":"Correlation analysis between regional FAPI uptake on PET and regional histopathological tumor scores."}
• {"endpoint_text":"- Expression of CAF content as measured by tumor-stroma ratio (TSR) on tissue samples from D1D2/CRITICS and relation with FAP expression.","definition_or_measurement_approach":"Measurement of tumor-stroma ratio (TSR) on tissue samples and assessment of relationship with FAP expression."}
• {"endpoint_text":"- Analysis of TSR and FAP expression and correlation to [18F]AlF-FAPI-74 PET/CT signal","definition_or_measurement_approach":"Analysis of TSR and FAP expression and correlation with PET/CT signal intensity."}
• {"endpoint_text":"- Analysis of all FAP expressing CAF subsets in obtained patient samples using imaging mass cytometry","definition_or_measurement_approach":"Characterisation of FAP-expressing CAF subsets using imaging mass cytometry on patient samples."}
• {"endpoint_text":"- Patient burden using a developed patient reported experience measure (PREM) questionnaire","definition_or_measurement_approach":"Assessment of patient burden via a developed PREM questionnaire."}
• {"endpoint_text":"- Quality of life as measured using the EORTC-QLQ-C30 and EQ-5D5L questionnaires and compared to PLASTIC","definition_or_measurement_approach":"Quality of life measured using EORTC-QLQ-C30 and EQ-5D-5L questionnaires and compared to PLASTIC study data."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Trial-based cost-effectiveness analysis calculating incremental cost-effectiveness ratio (ICER) of PET/CT vs staging laparoscopy using SL bottom-costing approach from PLASTIC cost analysis."}

Netherlands

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

250

Number Of Sites

12

Number Of Participants

250

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Dutch Cancer Society - Koningin Wilhelmina Fonds (KWF) voor kankerbestrijding","duties_or_roles":"Monetary support","organisation_type":""}