Gastric Cancer, Locally Advanced Gastric Adenocarcinoma, PET-CT, STOMACH NEOPLASM
Conditions
Keywords
FAPI, 18F-FAPI-74, PET/CT, Imaging biomarker, Gastrectomy, Gastric Cancer, Diagnostics
Brief summary
The goal of this clinical trial is to learn if a new type of scan, FAPI-PET/CT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases. The main questions it aims to answer are: * In how many patients can FAPI-PET/CT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)? * In how many patients does FAPI-PET/CT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed? Apart from the usual care gastric cancer patients receive, participants will: * Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time) * Complete a number of questionnaires, which will take approximately 4 hours in total
Interventions
DIAGNOSTIC_TEST[18F]FAPI-74 PET/CT
Patients included in the study will undergo FAPI-PET/CT after initial staging with gastroscopy and a contrast-enhanced CT of thorax and abdomen, but before undergoing a staging laparoscopy. Based on the results of the FAPI-PET/CT, the MDT and/or treating physician will decide on the next step: confirming possible malignant lesions on PET/CT by biopsies (either percutaneous of by staging laparoscopy), or in case of negative PET/CT, diagnostic laparoscopy.
DRUG[18F]-FAPI-74
\[18F\]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer
Sponsors
Leiden University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy; * Age greater than or equal to 18 years; * 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; * Patients must have given written informed consent; * 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
* Siewert type I-II esophagogastric junction tumor; * Unfit or unwilling to undergo study procedures; * Unfit or unwilling to undergo surgery; * Pregnancy at time of the \[18F\]AlF-FAPI-74 PET/CT scan, due to the investigational PET radiation burden; * Incapacitated subjects without decision-making capacity; * Medical or psychiatric conditions that compromise the patient's ability to give informed consent; * Illiterate patients unable to complete the resource use and quality of life questionnaires; * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in treatment intent | For each patient from enrollment through study completion, an average of 1 year. | 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) * The number of changes from curative to palliative treatment |
| Change in diagnostic work-up | Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy | 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 * The number of changes in extent of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of incidental and/or non-specific findings | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months] | 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. This includes five functional scales, three symptom scales, a global health status/QoL scale and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status / QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Patient burden | Immediately after completion of clinical staging (after post-diagnostic MDT). Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy. | Patient burden using a developed patient reported experience measure (PREM) questionnaire |
| Diagnostic time delay due to extra investigation | Immediately after completion of clinical staging (after post-diagnostic MDT). Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy. | Time between pre-diagnostic and post-diagnostic MDT meetings |
| Safety data regarding clinical use of [18F]FAPI-74 PET/CT | From start of injection of [18F]FAPI-74 up to 24 hours after administration. | The occurrence, type, and severity of (serious) adverse events |
| FAPI-PET based PCI scores | Immediately after staging laparoscopy, which takes place after FAPI-PET/CT. | 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 (this is done only for the LUMC patients). |
| Diagnostic performance | Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy | 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 reference test |
| FAP-expression | Baseline, before study procedure (for D1D2/CRITICS samples) and immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed, for PLASTIC-3 patients) | Expression of CAF content as measured by tumor-stroma ratio (TSR) on tissue samples from D1D2/CRITICS and relation with FAP expression. TSR according to van Pelt and Mesker et al. |
| TSR, FAP expression and FAPI-PET/CT signals | Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed) | Analysis of TSR and FAP expression and correlation to \[18F\]AlF-FAPI-74 PET/CT signal |
| FAP expressing CAF subsets | Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed) | Analysis of all FAP expressing CAF subsets in obtained patient samples using imaging mass cytometry |
| Health-related quality of life | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months | Quality of life as measured using the EORTC-QLQ-C30 questionnaire and compared to PLASTIC. The EORTC-QLQ-C30 includes five functional scales, three symptom scales, a global health status/QoL scale and six single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status / QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Costs of [18F]FAPI-74 PET/CT | At 3 and 12 months after completion of clinical staging | 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 and resource use questionnaires |
| FAPI uptake and histopathological tumor scores | Immediately after staging laparoscopy | Correlation between PCI-regional FAPI uptake and PCI-regional histopathological tumor scores (this is done only for LUMC patients). |
| Incidental findings | Immediately after completion of clinical staging. Clinical staging consists of FAPI-PET/CT, additional diagnostics following FAPI-PET/CT (if necessary to confirm suspect lesions on FAPI-PET/CT) and/or diagnostic laparoscopy | Proportion of patients with relevant incidental findings (e.g. second primary tumors) |
Countries
Netherlands
Contacts
Primary ContactSarah Spruijt, M.D.
Outcome results
None listed