Colorectal Cancer
Conditions
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.
Interventions
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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy (Area Under the ROC Curve [AUC]) of the MULTISCOPE Device for Differentiating Normal versus Neoplastic Colorectal Tissue | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Cell Destruction Rate After Cold Atmospheric Plasma (CAP) Exposure | 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. |
Contacts
CONTACTIVO BOSKOSKI
PRINCIPAL_INVESTIGATORIVO BOSKOSKI
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed