Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening: A Clinical Study in Brazil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.
详细描述
The investigators' hypothesis is that this mobile device with automated, AR optical biopsy diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to middle income countries (LMICs) with less experienced providers and is acceptable to providers and patients.
Objective 1: The investigators' first objective is to evaluate the marHRME technology in terms of performance, efficiency, and impact. In a single-arm, feasibility study (n=50) of high-risk subjects undergoing Lugol's chromoendoscopy (LCE) followed by marHRME for esophageal squamous cell neoplasia (ESCN) screening, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' main hypothesis is that the marHRME will:
- increase the accuracy of Lugol's endoscopy (LCE), other exploratory hypotheses are
- increase the accuracy of marHRME among novices and be non-inferior to experts,
- increase user confidence among experts and novices and, subsequently,
- increase the efficiency and impact of LCE by reducing biopsies and second procedures.
For performance for marHRME vs. Standard of Care, the investigators will compare the accuracy of the marHRME + LCE vs. LCE alone to the gold-standard histopathology (expert GI pathologist). For performance of the Machine vs. Man, the investigators will compare accuracy of the marHRME software read to novice and expert clinicians' subjective read to gold-standard histopathology. For clinician confidence and clinical impact, the investigators will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using marHRME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment including patients with known history of head/neck squamous cell cancer.
- •Patients must be >18 years old and able to give informed consent.
- •For the provider surveys and interviews, all providers (clinicians, trainees) who are working on the project will be eligible to participate.
排除标准
- •Allergy or prior reaction to the fluorescent contrast agent proflavine
- •Patients who are unable to give informed consent
- •Known advanced squamous cell carcinoma of the distal esophagus, or dyplastic/suspected malignant esophageal lesion greater than or equal to 2cm in size not amenable to endoscopic therapy
- •Patient unable to undergo routine endoscopy with biopsy
- •Women who are pregnant or breastfeeding
- •Prothrombin time greater than 50% of control; Partial Thromboplastin Time greater than 50 sec, or International Normalized Ratio greater than 2.0
- •inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues
- •Providers will be excluded if they decline participation or otherwise opt out of the proposed research project.
研究组 & 干预措施
Augmented Reality High Resolution Microendoscope (HRME) imaging
All study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging.
干预措施: Proflavine (Drug)
Augmented Reality High Resolution Microendoscope (HRME) imaging
All study subjects will receive White Light Imaging and Lugol's Chromoendoscopy (LCE) which is the current standard of care procedure. The investigators will record any LCE abnormal areas and record the clinician's plan of action. Following LCE, all subjects will receive Mobile, Augmented Reality High Resolution Microendoscope (marHRME) imaging with the study contrast agent (Proflavine) of any LCE-identified abnormal areas as well as LCE normal areas. The investigators will record the subjective clinician read and confidence level in the investigators' diagnosis, and plan of action. Then the investigators will image the same abnormal and normal areas with the marHRME and record the software read, clinician confidence level, and plan of action. Finally, the imaged areas will be biopsied or resected and evaluated by a pathologist. All subjects will receive both standard of care and marHRME imaging.
干预措施: Mobile, Augmented High Resolution Microendoscope (Device)
结局指标
主要结局
Diagnostic yield
时间窗: Day 1
The number of neoplastic biopsies/total number of biopsies obtained in patients who received biopsies.
Procedure time
时间窗: During Procedure
Total procedure time added by the HRME imaging.
'Patient saved'
时间窗: Day 1
The number of patients who received no biopsies.
次要结局
- Clinical impact(Day 1)