Lung CancerNCT05790226
Sentry Study: Raman Spectroscopy on Ex Vivo Lungs
A study testing Sentry System in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Sentry System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2023to 6 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or above,
- With suspected or confirmed diagnosis of lung cancer,
- Scheduled for lobectomy surgery,
- Able to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pre-Market Proof-of-Concept Study for Ex Vivo Raman Spectroscopy Measurements on Excised Lung Tissue With the Sentry System
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.
- Conditions
- Lung Cancer
- Being tested
- Sentry System
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentry SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Raman Spectroscopy | Experimental | Acquiring Raman spectroscopy data points ex vivo on recently excised lung tissue Receives: Device: Sentry System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start9 Jan 2023
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Why it stopped: Sponsor stopped study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790226
- Sponsor's protocol ID
- Sentry-2000-CIP-003
- Status last verified
- May 2024
- First submitted
- 25 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pre-Market Proof-of-Concept Study for Ex Vivo Raman Spectroscopy Measurements on Excised Lung Tissue With the Sentry System
- ClinicalTrials.gov ID
- NCT05790226
- Acronym / sponsor ID
- Sentry-2000-CIP-003
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped study
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raman Spectroscopy | Experimental | Device: Sentry SystemAcquiring Raman spectroscopy data points ex vivo on recently excised lung tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or above,
- With suspected or confirmed diagnosis of lung cancer,
- Scheduled for lobectomy surgery,
- Able to give informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentry Systemany 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. | Device | Raman Spectroscopy |
Primary outcome
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.
Time frame: 1 year
whether ex vivo cancerous and normal human lung tissue yield distinct Raman signatures.
Results and safety
The study was stopped early (reason given: Sponsor stopped study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentry System in people with Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor stopped study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.