DUAL
Research type
Research Study
Full title
Exploratory study to optically visualise activated neutrophils and the proto-oncogene, c-MET, in lung masses using DUAL colour fibre-based endomicroscopy
IRAS ID
201311
Contact name
Kev Dhaliwal
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
Lung cancer is one of the most common types of cancer. Understanding the molecules and processes involved in cancer is essential in order to diagnose and treat the disease more effectively. It is already known that a type of white blood cell, a neutrophil, and a protein (the building blocks of all cells) called c-MET, are vital to immune and normal cellular function, respectively. However, both of these have also been associated with cancer, making it important to understand more about their role in cancer and its development.
In an effort to address this outstanding question, the research team have designed and synthesised an imaging agent (Neutrophil Activation Probe (NAP)) that can detect activated neutrophils in the human lung. NAP, in combination with another optical imaging agent capable of detecting a cancer marker (c-MET, EMI-137) will be used at very low concentrations in patients with suspected or confirmed lung cancer scheduled for either a diagnostic bronchoscopy or a surgical procedure to remove some lung tissue. Both imaging agents are fluorescent and will light up areas of the lung where neutrophils and c-MET are present, and it is this light that the research team ultimately want to detect and analyse.
NAP and EMI-137 will be administered directly into the lungs during a bronchoscopy procedure using a novel delivery catheter device (a thin tube) and then imaged using a new imaging fibre (thin type of microscope). Both devices will be passed down the bronchoscope as part of one self-contained system. In addition, the research team have also built a detection system (Versicolour) which will be used to detect the signal emitted from both imaging agents. This study therefore involves the administration of fluorescent molecules using a new delivery catheter, a novel imaging fibre to capture the fluorescent signal and a detector system that has already been used in patients to display the images collected.
All patients will be monitored by the clinical research team for approximately 4-6 hours following dosing and various assessments and a chest x ray will be performed. Patients scheduled for tumour removal will be contacted 24 hours following the procedure to make sure that no problems were encountered. Patients scheduled for a diagnostic bronchoscopy will be invited back for another bronchoscopy shortly after their first round of cancer therapy to see if the activity of neutrophils and c-MET target changes before and after treatment.Summary of Results
The DUAL study was designed to image two imaging probes (NAP and EMI-137) using a dual colour imaging system that was compatible with clinical procedures. The focus was in patients with lung cancer to image their tumours during a procedure and to gain further information using these probes. NAP is designed to detect inflammation. Both imaging agents are fluorescent which means that they light up areas of the lung where these cells and proteins are present, and it is this light that we aim to detect using a small fibre-based microscope.
We successfully performed the procedure in 5 participants, and were able to image the tumours plus the probes. Furthermore, it was clear from basic analysis that we were imaging individual cells within the tumour and given the purpose, these were likely to be inflammatory cells within tumours. We have undertaken a descriptive assessment of the video frames, but there is insufficient participants with usable data for a more robust assessment.
Given this was the first time we have performed such procedures, the first few patients represented a learning curve for the methods of Smartprobe administration during a clinical bronchscopy procedure.
The study ended was terminated early as we did not have further access to EMI-137 (following expiry) and could additional EMI-137 not be re-manufactured, followed by the global pandemic, we decided to end the study.REC name
South East Scotland REC 02
REC reference
16/SS/0076
Date of REC Opinion
29 Apr 2016
REC opinion
Favourable Opinion