Sentry Study: Raman Spectroscopy on Ex Vivo Lungs

NCT ID: NCT05790226

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-11-06

Brief Summary

In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

Detailed Description

Lung cancer is the most prevalent form of cancer worldwide and the leading cause of cancer-related deaths. Despite recent advances in treatment, the five-year survival rate remains below 25% [State of Lung Cancer Report 2021,American Lung Association. This is largely due to the fact that most patients are diagnosed only at advanced stages of the disease when treatments are ineffective and the prognosis is poor. The National Lung Screening Trial demonstrated the utility of lung cancer screening by low-dose computed tomography (CT) to improve early detection\ and reduce lung cancer-related mortality by 20%. Earlier detection of lung lesions in turn created an increased need for better early diagnosis modalities.

Reveal Surgical is developing medical devices for tissue characterization based on Raman spectroscopy technology.

In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Raman Spectroscopy

Acquiring Raman spectroscopy data points ex vivo on recently excised lung tissue

Group Type: EXPERIMENTAL

Sentry System

Intervention Type: DEVICE

any labelling or contrast agents. The Sentry System uses the Sentry Probe, a flexible cable that terminates in a stylus that delivers a small beam of light to the surface of the excised tissue specimen and collects the Raman spectrum of the light coming back from the same area of the specimen.

Interventions

Sentry System

any labelling or contrast agents. The Sentry System uses the Sentry Probe, a flexible cable that terminates in a stylus that delivers a small beam of light to the surface of the excised tissue specimen and collects the Raman spectrum of the light coming back from the same area of the specimen.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged 18 or above,
• With suspected or confirmed diagnosis of lung cancer,
• Scheduled for lobectomy surgery,
• Able to give informed consent.

Exclusion Criteria

• Suspected or confirmed diagnosis of mucinous adenocarcinoma of the lung
• Undergoing neoadjuvant therapy. (This exclusion criterion is intended to minimize confounding optical signals such as fluorescence or near-infrared Raman signals that could arise from the presence of chromophores derived from neoadjuvant medication.)
• Previously diagnosed with cystic fibrosis or other lung disease, with the exception of Chronic Obstructive Pulmonary Disease (COPD) and ILD (Interstitial Lung Disease), i.e., patients with COPD or ILD will not be excluded from the study.
• Tumor size below 1cm3
• Resected lobe does not allow Surgical Pathology team to section two study specimens of minimal size 1.5cm × 1.5cm. In this case the patient will be found ineligible after consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Sentry-2000-CIP-003

Identifier Type: -

Identifier Source: org_study_id