Validation of an Artificial Intelligence System Based on Raman Spectroscopy (SPECTRA IMDx) for Real Time Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer in Patients Undergoing Gastric Endoscopic Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic performance of SPECTRA IMDx for assessment of lower risk lesion (GIM/LGD/Gastritis/Normal) and higher risk lesions (HGD/EGC) against the gold standard of histopathology from gastric resection specimen
研究概览
简要总结
Early detection and treatment of gastric premalignant lesion and early gastric cancer (EGC) have been proposed to improve outcomes of gastric cancer. Gastric dysplasia is a premalignant lesion and the penultimate stage in gastric carcinogenesis. On white light endoscopy (WLE), it is difficult to distinguish gastric dysplasia and EGC from benign pathology such as gastric intestinal metaplasia (GIM). Image enhanced endoscopy such as narrow-band imaging (NBI) is recommended to improve characterization of suspicious gastric lesions detected on WLE. Magnified-endoscopy with NBI (ME-NBI) have been shown to be superior to HD-WLE for diagnosis of GIM and EGC. Data on gastric dysplasia is less robust. Ultimately, biopsy is required to confirm diagnosis of gastric dysplasia/EGC. Gastric dysplasia can be classified into low-grade dysplasia (LGD) or high-grade dysplasia (HGD). Biopsy sampling may not be representative of the final histopathological grade of resected specimens and may under-stage dysplasia. Thus, endoscopic resection (ER) is recommended for gastric dysplasia and EGC on biopsy for diagnostic and therapeutic purpose. The current gap is to improve concordance of endoscopic and histologic findings of gastric dysplasia and early gastric cancer. Raman spectroscopy based artificial intelligence system (SPECTRA IMDx) was developed to provide an objective method to identify patients with gastric premalignant lesions and EGC. SPECTRA IMDx interrogate tissues at the cellular level and utilizes molecular information to provide actionable information to endoscopist during gastroscopy. Studies on diagnostic performance using Raman spectroscopy analysis devices have shown high sensitivity and specificity in detection of gastric cancer and precancerous lesions compared to WLE. However, these studies included few GIM, gastric dysplasia and gastric carcinoma. It is still unclear if Raman spectroscopy outperforms WLE in diagnosis of gastric HGD and EGC. In addition, the Raman spectroscopy algorithm is only able to characterize lesions into high risk (HGD/EGC) versus low risk (GIM/LGD/Gastritis/Normal). It is also uncertain if this technology is able to differentiate GIM and LGD. We plan to conduct a prospective trial to validate the diagnostic accuracy of SPECTRA for prediction of gastric HGD and EGC prior to gastric ER. Hypothesis: SPECTRA IMDx is able to differentiate higher risk lesions (HGD/EGC) from lower risk tissue/lesion (GIM/LGD/Gastritis/Normal)
详细描述
This is a prospective, single-centre study designed to evaluate the diagnostic performance of SPECTRA IMDx for real-time characterisation of gastric dysplasia and early gastric cancer for patients undergoing gastric endoscopic resection over a 24-month period.
Informed consent will be taken by the investigator before study enrolment. Subject participation in this study will last only the duration of the gastric endoscopic resection procedure and during surveillance gastroscopy. The duration of procedure may vary depending on the technical difficulty of the endoscopic resection performed, the size and number of suspicious lesions detected requiring biopsies. Subjects will not be required to make an additional visit to the hospital for the study.
Pre-endoscopic preparation and endoscopic procedure All antiplatelets except aspirin and all anticoagulants will be stopped before gastric endoscopic resection as per guideline.Full blood count and coagulation panel will be checked within one month before procedure to ensure no significant thrombocytopenia or coagulopathy. All patients on antiplatelets except aspirin and anticoagulation will be instructed to stop medications before procedure to reduce risk of bleeding.
All patients will be fasted and receive oral mucolytics prior to gastroscopy as per routine practice. Intravenous antispasmodics with either buscopan or glucagon will be administered to allow proper assessment of lesion prior to resection.
The Endoscopist will begin systemic examination of the stomach to inspect for presence of concomitant suspicious lesions and to identify the target lesion with dysplasia for endoscopic resection.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of gastric dysplasia with visible lesion or early gastric cancer amenable to gastric ER (EMR or ESD); diagnosis made based on biopsy from gastroscopy performed within past six months
- •Age 21 to 90 years (selected age range based on demographic of patients managed at Changi General Hospital)
- •Ability to provide informed consent
排除标准
- •Subjects without mental capacity, refusal to provide consent, incarcerated status, pregnant subjects.
- •Subjects with advanced gastric cancer not amenable to endoscopic resection
- •Subjects with bleeding disorders, such as haemophilia, in whom ER and biopsies are contraindicated.
- •Subjects with active bleeding or coagulopathy precluding ER and biopsies.
- •Subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
- •Subjects on regular anti-platelet medications except aspirin or anti-coagulants must be able to undergo adequate washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
结局指标
主要结局
Diagnostic performance of SPECTRA IMDx for assessment of lower risk lesion (GIM/LGD/Gastritis/Normal) and higher risk lesions (HGD/EGC) against the gold standard of histopathology from gastric resection specimen
时间窗: 24 months
Diagnostic performance: accuracy, positive predictive value and negative predictive value
次要结局
- Feasibility of Raman spectroscopy to differentiate GIM, LGD, HGD and EGC against the gold standard of histopathology(24 months)
- Feasibility of Raman spectroscopy to identify gastric dysplasia and EGC from scar tissues post-ER during surveillance endoscopy.(24 months)
- Comparison of diagnostic performance of SPECTRA IMDx versus HD-WLE for assessment of high grade dysplasia/early gastric cancer(24 months)
- Evaluation of performance of HD-WLE combined with NBI in detection of HGD/EGD prior to ER.(24 months)