[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
[18F]FAPI-74 PET/CT
Diagnostic testPatients 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.
[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
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: [18F]-FAPI-74 PET/CTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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: * The number of prevented unnecessary surgeries (staging laparoscopies and/or gastrectomies) * The number of changes from curative to palliative treatment
Time frame
For each patient from enrollment through study completion, an average of 1 year.2
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: * The number of additional biopsies or longitudinal imaging * The number of changes in extent of surgery
Time frame
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 laparoscopySecondary outcomes
1
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
Time frame
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 laparoscopy2
Incidental findings
Proportion of patients with relevant incidental findings (e.g. second primary tumors)
Time frame
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 laparoscopy3
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.
Time frame
At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]4
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.
Time frame
At enrollment, after completion of clinical staging but before starting treatment, after completion of clinical staging at 3, 6, 9 and 12 months]Sponsors and contacts
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Source ClinicalTrials.gov