Sentry Study: Raman Spectroscopy on Ex Vivo Lungs

NCT05790226 | Terminated

• 1 other identifier: Sentry-2000-CIP-003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• investigate the variability of the Raman spectra using data points ex vivo on recently excised lung tissue, with at least one third of spectra labeled as normal and cancerous based on subsequent histopathology assessment.

  whether ex vivo cancerous and normal human lung tissue yield distinct Raman signatures.

  1 year

Study Arms (1)

Raman Spectroscopy

EXPERIMENTAL

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

Device: Sentry System

Interventions

Sentry System 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.

Raman Spectroscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Suspected or confirmed diagnosis of mucinous adenocarcinoma of the lung
• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: January 25, 2023
• First Posted: March 30, 2023
• Study Start: January 9, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)