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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: IVO BOSKOSKI
- 전화번호: +39 06 3015 6580
- 이메일: ivo.boskoski@policlinicogemelli.it
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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).
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue
기간: At the time of histopathological evaluation, approximately 2 weeks after the surgical procedure.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure
기간: Up to 12 months (at the end of the study).
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The therapeutic efficacy of MULTISCOPE expressed as the proportion of treated/affected cells after CAP exposure, quantified in commercial gastrointestinal tumor organoids.
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Up to 12 months (at the end of the study).
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공동 작업자 및 조사자
수사관
- 수석 연구원: IVO BOSKOSKI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 8118 (Fred Hutch/University of Washington Cancer Consortium)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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