NCT02676050

Visualising c-MET and Activated Neutrophils in Lung Cancer

Exploratory Study to Optically Visualise Activated Neutrophils and the Proto-oncogene, c-MET, in Lung Cancer Using DUAL Colour Fibre-based Endomicroscopy

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	Optical Imaging Agents (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.
DEVICE	Delivery Device Cathetar and Miniaturised imaging fibre	Both optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above.
DEVICE	Optical endomicroscopy system	The signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system.

Timeline

• Start date: 2019-10-04
• Primary completion: 2021-12-20
• Completion: 2022-03-20
• First posted: 2016-02-08
• Last updated: 2023-12-04

Locations

1 site across 1 country: United Kingdom