- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858970
Diagnostic Accuracy of Real-time Optical Biopsy (INSTASCOPE)
In Vitro Pilot Study to Assess the Diagnostic Accuracy of Real-time Optical Biopsy Based on Multimodal Optical Fibers.
Differentiating neoplastic tissue from healthy tissue is fundamental for both early diagnosis during endoscopic examinations and radicality of the oncological interventions. Currently, histology is the gold standard for both diagnosis and evaluation of resection margins. However, it is time-consuming and can be performed only postoperatively. As such, the development of an ultra-sensitive method for real-time optical diagnosis may have a groundbreaking impact in this clinical setting. Recently, it has been developed a novel diagnostic methodology based on the evolution of non-linear optics systems that employs a multiphoton laser, is based on the complex propagation of light in multimodal optical fibers (MMFs - Multimodal Fibers). And allows multiplex Coherent Anti-Stokes Raman Spectroscopy (CARS) imaging to obtain a molecular fingerprint of the tissue. The molecular constitution and the structural alterations of the tissues can be detected by analyzing both the vibrational properties and the harmonic generation and the endogenous fluorescence of living matter, allowing to obtain an "optical diagnosis". The methodology uses a multiphoton laser (Femtosecond tunable laser system), is marker-free and safe for biological tissues, and allows extremely high-resolution imaging. The diagnostic methodology has been already evaluated on two-dimensional cell cultures. ESD is a well-established technique for the minimally invasive endoscopic resection of large and irregularly shaped superficial neoplastic lesions of the gastrointestinal tract with high en-bloc and margin-negative resection rates. The technique requires "safe margins" of resection of about 5 to 8 mm around the neoplastic tissue. As such, this resection specimen includes both neoplastic and normal tissue of "safe margins".
On this background, this study is aimed at evaluating the methodology of imaging based on MMFs on normal and tumor tissues. The investigators plan to perform an in-vitro prospective diagnostic comparative pilot study between standard histology and optical biopsy with MMFs. The study will include 27 consecutive specimens of colorectal lesions resected with endoscopic submucosal dissection (ESD). Each ESD-resected lesion will be also the control group since it consists of surrounding safe margins (healthy tissue) and central tumor formation (tumoral tissue). The demonstration of in-vitro optical diagnosis with MMFs will include normal-to-normal and tumor-to-tumor comparisons. The laser system will be placed over a precise place with normal mucosa of the resected specimen and the characteristics of the mucosa will be registered. The same mucosa will then be indicated for histological analysis. The procedure will be repeated on tumoral tissue with the same methodology. The primary endpoint of this protocol is the diagnostic accuracy of the optical biopsy with MMFs. The results of optical biopsy will be expressed as the CARS signal difference between healthy and tumor tissues. The power to discriminate between healthy and cancer tissues will be determined using a ROC (Receiver Operating Characteristic) curve. The ROC curve will be obtained by determining the number of correct and incorrect classifications as a function of the threshold value to discriminate between the two groups.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Colonic or rectal neoplastic lesions resected by ESD
- Age ≥ 18 years
- Signed informed consent
Exclusion Criteria:
- Refusal to sign informed consent
- Technical non-feasibility of ESD
- Severe medical comorbidities contraindicating ESD
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic accuracy of the optical biopsy with MMFs.
Time Frame: through study completion, an average of 1 year
|
The power to discriminate between healthy and cancer tissues will be determined using a ROC (Receiver Operating Characteristic) curve
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ID 5485
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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