In Vitro Pilot Study to Assess the Diagnostic Accuracy of the Device Under Development MULTISCOPE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue
研究概览
简要总结
Conventional gastrointestinal endoscopy relies on ex vivo histopathology, a process limited by diagnostic delays and high costs. The MULTISCOPE project introduces a miniaturized (2.2 mm) endoscopic device integrating advanced optical biopsy with Cold Argon Plasma (CAP) therapy. Utilizing multimodal optical fibers, the system performs label-free, high-resolution imaging via two-photon autofluorescence and second-harmonic generation.
Simultaneously, the integrated CAP technology enables targeted oncological treatment by inducing apoptosis and cell-cycle arrest with minimal collateral damage. Given that Endoscopic Submucosal Dissection (ESD) inherently provides samples containing both neoplastic and healthy margins (5-8 mm safety zone), this platform allows for precise, real-time tissue characterization. This in vitro pilot study evaluates the system's diagnostic accuracy in discriminating between healthy and neoplastic colorectal tissues.
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
- •Colonic or rectal neoplastic lesions resectable by endoscopic submucosal dissection (ESD)
- •Age ≥ 18 years, male and female
- •patients with American Society of Anesthesiologists (ASA) grades 1-3
- •Signed informed consent
排除标准
- •Severe medical comorbidities precluding endoscopy;
- •Uncontrolled coagulopathy;
- •Pregnancy or planned pregnancy during the period of study participation;
- •Life expectancy ≤2 years, as judged by the site investigator;
- •Refusal to sign the informed consent.
研究组 & 干预措施
Patients who require endoscopy with endoscopic submucosal dissection (ESD) of the colon.
Thirty consecutive colorectal specimens resected via endoscopic submucosal dissection (ESD) will be analyzed. Each specimen serves as an internal control, comprising both central neoplasia and healthy peripheral margins ("fried-egg" morphology). To ensure maximum accuracy with this novel device, optical biopsies will be performed on both tissue types immediately prior to formal histopathological fixation. ESD procedures will be conducted at the Agostino Gemelli Foundation, while optical and histopathological analyses will be centralized at the Catholic University of Rome (UCSC).
干预措施: endoscopic submucosal dissection (ESD) (Procedure)
结局指标
主要结局
Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue
时间窗: At the time of histopathological evaluation, approximately 2 weeks after the surgical procedure.
The diagnostic accuracy of optical biopsies performed with the two-photon microendoscope MULTISCOPE prototype will be assessed and compared against standard ex vivo histopathology (gold standard) as the reference diagnosis. Diagnostic performance will be evaluated based on the Area Under the Receiver Operating Characteristic Curve (AUC). Optimal sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with 95% confidence intervals will also be calculated using the Youden Index threshold. AUC values range from 0.5 (no discrimination) to 1.0 (perfect diagnostic accuracy).
次要结局
- Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure(Up to 12 months (at the end of the study).)