The Diagnostic Accuracy of the Device Under Development MULTISCOPE

NCT07826611 | Not Yet Recruiting

• 1 other identifier: 8118
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue

  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.

Secondary Outcomes (1)

• Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure

  Up to 12 months (at the end of the study).

Study Arms (1)

Patients who require endoscopy with endoscopic submucosal dissection (ESD) of the colon.

EXPERIMENTAL

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).

Procedure: endoscopic submucosal dissection (ESD)

Interventions

endoscopic submucosal dissection (ESD) PROCEDURE

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.

Patients who require endoscopy with endoscopic submucosal dissection (ESD) of the colon.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• IVO BOSKOSKI

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IVO BOSKOSKI

CONTACT

+39 06 3015 6580; ivo.boskoski@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: September 17, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 17, 2026

Record last verified: 2025-12