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TerminatedNCT05790226Updated May 8, 2024

Sentry Study: Raman Spectroscopy on Ex Vivo Lungs

An interventional study of Sentry System in Lung Cancer, sponsored by University Health Network, Toronto. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Sponsor stopped study
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Raman Spectroscopy

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

    Device: Sentry System

Interventions

  • DeviceSentry 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.

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05790226
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 30, 2023
Start date
Jan 9, 2023
Primary completion
Nov 6, 2023
Completion
Nov 6, 2023
Last update
May 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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