[18F]F-FAPI PET/CT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Change in treatment intent
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
[18F]-FAPI-74 PET/CT
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.
干预措施: [18F]FAPI-74 PET/CT (Diagnostic Test)
[18F]-FAPI-74 PET/CT
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.
干预措施: [18F]-FAPI-74 (Drug)
结局指标
主要结局
Change in treatment intent
时间窗: 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
时间窗: 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
次要结局
- 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)
- Impact of incidental and/or non-specific 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.)
- 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)
- FAPI uptake and histopathological tumor scores(Immediately after staging laparoscopy)
- TSR, FAP expression and FAPI-PET/CT signals(Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed))
- 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.)
- 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.)
- 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))
- FAP expressing CAF subsets(Immediately after gastrectomy or immediately after staging laparoscopy (if no gastrectomy is performed))
- 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.)
- FAPI-PET based PCI scores(Immediately after staging laparoscopy, which takes place after FAPI-PET/CT.)
- Costs of [18F]FAPI-74 PET/CT(At 3 and 12 months after completion of clinical staging)
- 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)
研究者
Lioe-Fee de Geus-Oei, MD PhD
Prof. dr.
Leiden University Medical Center