Lung CancerEarly Phase 1DUALNCT02676050
Visualising c-MET and Activated Neutrophils in Lung Cancer
A Early Phase 1 study testing Optical Imaging Agents (EMI-137, NAP), Delivery Device Cathetar and Miniaturised imaging fibre and Optical endomicroscopy system in people with Lung Cancer, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Lung cancer is currently a major health problem in the UK. Despite being one of the most common cancers, lung cancer has a poor prognosis compared to other types of cancer and is the leading cause of cancer death in the world. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Optical Imaging Agents (EMI-137, NAP), Delivery Device Cathetar and Miniaturised imaging fibre and Optical endomicroscopy system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2019to 20 Mar 2022
- Phase
- Early Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with inoperable stage 3 or 4 lung cancer
- ≥ 16 years
- Provision of informed consent from the patient prior to any study related procedures.
- Normal electrocardiogram (ECG)
- Forced Expiratory Volume (FEV1) >1L
- Thoracic CT scan taken in the last 20 weeks
- Attending consultant permission for bronchoscopy
- Readily accessible target areas with bronchoscopy and FE
Who cannot join
- Refusal for participation by attending consultant
- Unsuitable for bronchoscopy
- Any history of anaphylaxis
- Significant coagulopathy, which causes bronchoscopy to be unsuitable, as determined by clinical co-investigator or the participant's attending consultant, using information which is routinely available
- Myocardial infarction in the preceding four weeks
- Women who are pregnant or are breastfeeding
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- Receiving drugs that cause increased autofluorescence in the lung, specifically amiodorane and methotrexate
- Oxygen saturation <92% breathing room air
- Platelet count < 50 x 109/L
- Bleeding diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study to Optically Visualise Activated Neutrophils and the Proto-oncogene, c-MET, in Lung Cancer Using DUAL Colour Fibre-based Endomicroscopy
Lung cancer is currently a major health problem in the UK. Despite being one of the most common cancers, lung cancer has a poor prognosis compared to other types of cancer and is the leading cause of cancer death in the world. As opposed to other organs, the lung is highly susceptible to inflammatory insults, for example from bacterial infection-induced and tobacco-induced inflammation. It has long been known that the cellular microenvironment that nurtures tumour growth and development is linked to sites of chronic inflammation but molecular insights into how external inflammation boosts or inhibits cancer in the lungs remains unclear. This study aims to directly visualise the expression of a well known marker of cancerous tissue, c-MET, and the activity of neutrophils in human lung cancer in vivo in situ using fibre-based endomicroscopy.
Read the detailed description
The primary objective of this study is to directly deliver a microdose of two optical imaging agents to 20 patients with suspected or confirmed lung cancer to assess whether the agents can detect c-MET expression and neutrophil activity in human lung cancer.
The primary endpoint is to visualise the delivery of these imaging agents to assess imaging parameters in patients with suspected or diagnosed lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
This protocol will involve two cohorts of patients; Cohort 1 will include patients scheduled for resection of their lung cancer and Cohort 2 will be patients with suspected inoperable stage 3/4 lung cancer scheduled for a diagnostic bronchoscopy followed by therapy. For both cohorts, eligibility will be verified by a clinical trial physician after written informed consent has been obtained.
Fibre-based endomicroscopy (FE) will be performed and up to 100μg of both optical imaging agents will be instilled during a bronchoscopy procedure. CT identified regions of architecturally normal lung in all participants will act as internal controls and will be used to compare the signal in normal and diseased lung tissue. Tissue samples taken from both cohorts will be collected for ex vivo validation including immunohistochemistry, zymography and genomic screening.
A cardiorespiratory exam, chest x ray and routine observations will be performed 4-6 hours following the administration of both imaging agents. All participants will be visited by a member of the research team 24 hours (± 4 hours) after dosing to ensure no adverse events were experienced. All participants in Cohort 1 will complete the study when the 24 hour assessment has been successfully completed and all adverse events have been resolved. Participants in Cohort 2 will be invited back for a second bronchoscopy following the first round of their therapy to investigate whether the expression of c-MET or the level of neutrophil activity has changed. All participants in Cohort 2 will complete the study when the second 24 hour assessment has been successfully completed and all adverse events have been resolved.
- Conditions
- Lung Cancer
- Being tested
- Optical Imaging Agents (EMI-137, NAP), Delivery Device Cathetar and Miniaturised imaging fibre, Optical endomicroscopy 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.
Optical Imaging Agents (EMI-137, NAP)Other
Also called EMI-137, NAP
Both optical imaging agents (NAP and EMI-137) will be administered to each patient during a bronchoscopy procedure. A novel delivery catheter (to deliver both agents), imaging fibre and endomicroscopy system with viewer software will be used to detect c-MET and activated neutrophil signal in the human lung.
Delivery Device Cathetar and Miniaturised imaging fibreDevice
Both optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above.
Optical endomicroscopy systemDevice
The signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system.
| Study group | Role | What they receive |
|---|---|---|
| Imaging agents and imaging devices | Experimental | All participants in Cohort 1 will be dosed on one occasion with the optical imaging agents and Cohort 2 can be dosed twice per agent. The final dosage will be <100ug per agent. The agents will be delivered using a novel delivery catheter and imaged with a novel imaging fibre and microendoscopy system. Receives: Other: Optical Imaging Agents (EMI-137, NAP); Device: Delivery Device Cathetar and Miniaturised imaging fibre; Device: Optical endomicroscopy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of optical agents in the lung
The primary endpoint of this clinical investigation is to image the delivery of the optical imaging agents in human lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
Measured: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
Secondary outcomes (3)
Quantification of signal of imaging agents
To determine whether neutrophil activation and c-MET activity are increased in human lung cancer in vivo in situ
Measured: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
Ability of novel device to deliver agents and image simultaneously
To determine if the novel delivery catheter can co-deliver imaging agents and image simultaneously
Measured: Within 5 minutes
Whether expression correlates with treatment response
To establish if neutrophil activity and c-MET upregulation can predict stage 3/4 tumour response to either chemotherapy or radiotherapy (Cohort 2).
Measured: Within 4-6 weeks following first round of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start4 Oct 2019
- Primary completion20 Dec 2021
- Study completion20 Mar 2022
Why it stopped: C-met marker expired
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 of EdinburghThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Kev Dhaliwal, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676050
- Sponsor's protocol ID
- DUAL
- Acronym
- DUAL
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2016
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Optically Visualise Activated Neutrophils and the Proto-oncogene, c-MET, in Lung Cancer Using DUAL Colour Fibre-based Endomicroscopy
- ClinicalTrials.gov ID
- NCT02676050
- Acronym / sponsor ID
- DUAL / DUAL
- Conditions
- Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: C-met marker expired
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 8 Feb 2016 (estimated)
- 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.
Lung cancer is currently a major health problem in the UK. Despite being one of the most common cancers, lung cancer has a poor prognosis compared to other types of cancer and is the leading cause of cancer death in the world. As opposed to other organs, the lung is highly susceptible to inflammatory insults, for example from bacterial infection-induced and tobacco-induced inflammation. It has long been known that the cellular microenvironment that nurtures tumour growth and development is linked to sites of chronic inflammation but molecular insights into how external inflammation boosts or inhibits cancer in the lungs remains unclear. This study aims to directly visualise the expression of a well known marker of cancerous tissue, c-MET, and the activity of neutrophils in human lung cancer in vivo in situ using fibre-based endomicroscopy.
Detailed description
The primary objective of this study is to directly deliver a microdose of two optical imaging agents to 20 patients with suspected or confirmed lung cancer to assess whether the agents can detect c-MET expression and neutrophil activity in human lung cancer.
The primary endpoint is to visualise the delivery of these imaging agents to assess imaging parameters in patients with suspected or diagnosed lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
This protocol will involve two cohorts of patients; Cohort 1 will include patients scheduled for resection of their lung cancer and Cohort 2 will be patients with suspected inoperable stage 3/4 lung cancer scheduled for a diagnostic bronchoscopy followed by therapy. For both cohorts, eligibility will be verified by a clinical trial physician after written informed consent has been obtained.
Fibre-based endomicroscopy (FE) will be performed and up to 100μg of both optical imaging agents will be instilled during a bronchoscopy procedure. CT identified regions of architecturally normal lung in all participants will act as internal controls and will be used to compare the signal in normal and diseased lung tissue. Tissue samples taken from both cohorts will be collected for ex vivo validation including immunohistochemistry, zymography and genomic screening.
A cardiorespiratory exam, chest x ray and routine observations will be performed 4-6 hours following the administration of both imaging agents. All participants will be visited by a member of the research team 24 hours (± 4 hours) after dosing to ensure no adverse events were experienced. All participants in Cohort 1 will complete the study when the 24 hour assessment has been successfully completed and all adverse events have been resolved. Participants in Cohort 2 will be invited back for a second bronchoscopy following the first round of their therapy to investigate whether the expression of c-MET or the level of neutrophil activity has changed. All participants in Cohort 2 will complete the study when the second 24 hour assessment has been successfully completed and all adverse events have been resolved.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging agents and imaging devices | Experimental | Other: Optical Imaging Agents (EMI-137, NAP), Device: Delivery Device Cathetar and Miniaturised imaging fibre, Device: Optical endomicroscopy systemAll participants in Cohort 1 will be dosed on one occasion with the optical imaging agents and Cohort 2 can be dosed twice per agent. The final dosage will be <100ug per agent. The agents will be delivered using a novel delivery catheter and imaged with a novel imaging fibre and microendoscopy system. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with inoperable stage 3 or 4 lung cancer
- ≥ 16 years
- Provision of informed consent from the patient prior to any study related procedures.
- Normal electrocardiogram (ECG)
- Forced Expiratory Volume (FEV1) >1L
Key exclusion criteria (10 listed)
- Refusal for participation by attending consultant
- Unsuitable for bronchoscopy
- Any history of anaphylaxis
- Significant coagulopathy, which causes bronchoscopy to be unsuitable, as determined by clinical co-investigator or the participant's attending consultant, using information which is routinely available
- Myocardial infarction in the preceding four weeks
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 |
|---|---|---|
| Optical Imaging Agents (EMI-137, NAP)Also: EMI-137, NAPBoth optical imaging agents (NAP and EMI-137) will be administered to each patient during a bronchoscopy procedure. A novel delivery catheter (to deliver both agents), imaging fibre and endomicroscopy system with viewer software will be used to detect c-MET and activated neutrophil signal in the human lung. | Other | Imaging agents and imaging devices |
| Delivery Device Cathetar and Miniaturised imaging fibreBoth optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above. | Device | Imaging agents and imaging devices |
| Optical endomicroscopy systemThe signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system. | Device | Imaging agents and imaging devices |
Primary outcome
The measurement of optical agents in the lung
Time frame: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
The primary endpoint of this clinical investigation is to image the delivery of the optical imaging agents in human lung cancer using a novel delivery catheter, imaging fibre and fibre-based endomicroscopy system.
3 secondary outcomes
Quantification of signal of imaging agents
Time frame: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.
Ability of novel device to deliver agents and image simultaneously
Time frame: Within 5 minutes
Whether expression correlates with treatment response
Time frame: Within 4-6 weeks following first round of therapy
Results and safety
The study was stopped early (reason given: C-met marker expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
Kev Dhaliwal, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Optical Imaging Agents (EMI-137, NAP), Delivery Device Cathetar and Miniaturised imaging fibre and Optical endomicroscopy system in people with Lung Cancer, run by University of Edinburgh at 1 site in United Kingdom.
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 8 inclusion and 10 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 3 Jun 2026. 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 United Kingdom. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: C-met marker expired). 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?
The measurement of optical agents in the lung (time frame: On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.). 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 3 Jun 2026.