Visualising c-MET and Activated Neutrophils in Lung Cancer

NCT02676050 | Terminated Early Phase 1 DMC

• 1 other identifier: DUAL
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  On average, fluorescence signal can be detected within 5 minutes following optical imaging agent administration.

Secondary Outcomes (3)

• Quantification of signal of imaging agents

  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

  Within 5 minutes

• Whether expression correlates with treatment response

  Within 4-6 weeks following first round of therapy

Study Arms (1)

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.

Other: Optical Imaging Agents (EMI-137, NAP); Device: Delivery Device Cathetar and Miniaturised imaging fibre; Device: Optical endomicroscopy system

Interventions

Optical Imaging Agents (EMI-137, NAP) OTHER

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.

Also known as: EMI-137, NAP

Imaging agents and imaging devices

Delivery Device Cathetar and Miniaturised imaging fibre DEVICE

Both optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above.

Imaging agents and imaging devices

Optical endomicroscopy system DEVICE

The signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system.

Imaging agents and imaging devices

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4TJ, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kev Dhaliwal, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 8, 2016
• Study Start: October 4, 2019
• Primary Completion: December 20, 2021
• Study Completion: March 20, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)