Diagnostic Accuracy of Real-time Optical Biopsy (INSTASCOPE)

February 27, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Status

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Not yet recruiting

Conditions

Conditions

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Study Type

Study Type

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Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal lesions resected with endoscopic submucosal dissection (ESD).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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