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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513255-32-00 | EU Trial (CTIS) Number |
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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:
Apart from the usual care gastric cancer patients receive, participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]-FAPI-74 PET/CT | Experimental | 3.0 MBq [18F]-FAPI-74 will be administered intravenously 60 minutes before PET/CT scanning. Scanning time will be dependent on the type of scanner in the participating center, but will take approximately 20 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FAPI-74 PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in treatment intent | 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:
| For each patient from enrollment through study completion, an average of 1 year. |
| Change in diagnostic work-up | 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Spruijt, M.D. | Contact | +31 71 526 6029 | s.w.j.m.spruijt@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZGT | Not yet recruiting | Almelo | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41299326 | Derived | Triemstra L, Spruijt SWJM, Vriens D, Vegt E, Mesker WE, Hawinkels LJAC, Saing S, Slingerland M, Kemp V, Crobach SALP, Goeman JJ, Pool M, Dibbets-Schneider P, Bennink RJ, van Berge Henegouwen MI, van Det MJ, van Etten BJ, Hartgrink HH, van Hillegersberg R, Lam MGEH, Smulders NM, Luyer MDP, Noordzij W, Owers EC, Oyen WJG, van Sandick JW, Schreurs W, de Steur WO, Stoot JHMB, Weijs LE, Wijnhoven BPL, Witteman BPL, Ruurda JP, de Geus-Oei LF; PLASTIC-3 Study Group. [18F]F-FAPI PET/CT and LAparoscopy in STagIng advanced gastric Cancer: a multicenter prospective study (PLASTIC-3 study). BMC Cancer. 2025 Nov 27;26(1):135. doi: 10.1186/s12885-025-15347-7. |
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Individual participant data that underlie the results reported in this article, after deidentification, and only of participants who have given informed consent to share their data for other research purposes will be shared.
Beginning 3 months and ending 5 years following article publication.
Investigators with an approved proposal by a review committee may be granted access to research data upon reasonable request, provided necessary privacy provisions are in place. Only data from participants who have given informed consent for its use in other research is included.
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| [18F]-FAPI-74 | Drug | [18F]-FAPI-74 will be administered intravenously 60 minutes before PET/CT-scanning to be able to detect (metastases of) gastric cancer |
|
| Incidental findings | Proportion of patients with relevant incidental findings (e.g. second primary tumors) | 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 |
| Impact of incidental and/or non-specific findings | 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. | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months] |
| Impact of incidental and/or non-specific findings | Patients' extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using EQ-5D-5L. This comprises 5 dimensions and each dimension has five response levels, from no problems to unable to/extreme problems. Health states can be summarised using a 5 digit code (one digit for each dimension, no problems is coded as one and extreme problems as 5 and everything in between, e.g. 21111) or represented by a single summary number (index value), through which QALY's can be calculated. The index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months] |
| Impact of incidental and/or non-specific findings | Patients' extra burden of undergoing additional diagnostics due to incidental and/or non-specific [18F]AlF-FAPI-74 PET/CT findings using a Patient Reported Experience Measure (PREM) questionnaire. This includes questions designed to capture the differences in patient burden between imaging with FAPI-PET/CT and staging laparoscopy. The scale ranges from 1 (strongly agree/not annoying at all) to 5 (strongly disagree/very annoying). A higher score represents a worse outcome. | 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 time delay due to extra investigation | Time between pre-diagnostic and post-diagnostic MDT meetings | 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. |
| Safety data regarding clinical use of [18F]FAPI-74 PET/CT | The occurrence, type, and severity of (serious) adverse events | From start of injection of [18F]FAPI-74 up to 24 hours after administration. |
| FAPI-PET based PCI scores | 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). | Immediately after staging laparoscopy, which takes place after FAPI-PET/CT. |
| FAPI uptake and histopathological tumor scores | Correlation between PCI-regional FAPI uptake and PCI-regional histopathological tumor scores (this is done only for LUMC patients). | Immediately after staging laparoscopy |
| FAP-expression | 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. | 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) |
| TSR, FAP expression and FAPI-PET/CT signals | Analysis of TSR and FAP expression and correlation to [18F]AlF-FAPI-74 PET/CT signal | Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed) |
| FAP expressing CAF subsets | Analysis of all FAP expressing CAF subsets in obtained patient samples using imaging mass cytometry | Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed) |
| Patient burden | Patient burden using a developed patient reported experience measure (PREM) questionnaire | 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. |
| Health-related quality of life | 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. | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months |
| Health-related quality of life | Quality of life as measured using the EQ-5D5L questionnaire and compared to PLASTIC. This comprises 5 dimensions and each dimension has five response levels, from no problems to unable to/extreme problems. Health states can be summarised using a 5 digit code (one digit for each dimension, no problems is coded as one and extreme problems as 5 and everything in between, e.g. 21111) or represented by a single summary number (index value), through which QALY's can be calculated. The index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. | At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months |
| Costs of [18F]FAPI-74 PET/CT | 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 | At 3 and 12 months after completion of clinical staging |
| Amsterdam UMC | Not yet recruiting | Amsterdam | Netherlands |
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| Netherlands Cancer Institute - Antoni van Leeuwenhoek | Not yet recruiting | Amsterdam | Netherlands |
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| Rijnstate | Not yet recruiting | Arnhem | Netherlands |
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| Catharina Ziekenhuis | Not yet recruiting | Eindhoven | Netherlands |
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| Zuyderland | Not yet recruiting | Geleen | Netherlands |
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| UMC Groningen | Not yet recruiting | Groningen | Netherlands |
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| Leids Universitair Medisch Centrum | Recruiting | Leiden | Netherlands |
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| Erasmus MC | Not yet recruiting | Rotterdam | Netherlands |
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| UMC Utrecht | Not yet recruiting | Utrecht | Netherlands |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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