The Diagnostic Accuracy of the Device Under Development MULTISCOPE (MULTISCOPE)
In Vitro Pilot Study to Assess the Diagnostic Accuracy of the Device Under Development MULTISCOPE
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：IVO BOSKOSKI
- 電話番号：+39 06 3015 6580
- メール：ivo.boskoski@policlinicogemelli.it
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
Protocol and Transport Colorectal ESD specimens will be resected at the Fondazione Gemelli IRCCS and immediately transported dry (without formalin) to the UCSC Pathological Anatomy Unit within 15 minutes. To ensure tissue viability, dedicated staff will coordinate the transfer directly from the endoscopy suite. Ex Vivo Analysis The MULTISCOPE device will be stationed at the UCSC facility, adjacent to the pathology lab. Upon arrival, Prof. Vincenzo Arena's team will perform multimodal fiberoptic optical biopsies on both healthy and neoplastic mucosa before proceeding with standard histopathological processing. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue
時間枠：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). |
At the time of histopathological evaluation, approximately 2 weeks after the surgical procedure.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure
時間枠：Up to 12 months (at the end of the study).
|
The therapeutic efficacy of MULTISCOPE expressed as the proportion of treated/affected cells after CAP exposure, quantified in commercial gastrointestinal tumor organoids.
|
Up to 12 months (at the end of the study).
|
協力者と研究者
捜査官
- 主任研究者：IVO BOSKOSKI、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 8118 (Fred Hutch/University of Washington Cancer Consortium)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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