Imaging FIB ONE in the Human Lung Using Endomicroscopy

Summary

While the process of fibrosis is essential for normal wound healing, an excessive and uncontrolled 'fibrotic' response can result in impaired tissue structure and function. In other words, affected 'fibrotic' tissues are unable to heal back to normal and therefore don't work as effectively as they normally would.

In the case of the lung, fibrosis can occur across large parts of the lung such as in conditions like Idiopathic Pulmonary Fibrosis (IPF) and sarcoidosis or it can occur in much smaller patches such as around the borders of some lung tumours. At the moment the investigators don't fully understand the mechanisms of fibrosis and so therefore cannot monitor or treat these conditions as effectively as the investigators could. Despite the significant global financial burden of these diseases, treatment options are very limited and monitoring of disease progression remains a real challenge.

In an effort to address this problem, the research group are currently developing a library of novel optical molecular imaging SmartProbes that are targeted against key pathological processes in the human lung. The functional profile for this portfolio of probes is that they exhibit high stability and specificity in vivo and have a short activation time permitting rapid point-of-care in situ molecular profiling enabling in the future, improved diagnostic certainty and stratification for targeted pharmacological intervention. This clinical microdosing study protocol focuses around the intrapulmonary delivery of microdoses (\<100µg) of the Smartprobe Fibroproliferation (FIB ONE) to disparate regions of the human lung to highlight MMP activity combined with an active MMP inhibitor (AZD1236) to the distal lung. This approach will enable the research team to directly demonstrate the utility of this SmartProbe-based platform in the validation of drug target engagement in areas of suspected fibroproliferation (characterised by increased MMP activity).

Conditions

• Fibrosis
• Lung Cancer

Interventions

OTHER

FIB ONE

FIB ONE will be administered to each patient during a bronchoscopy procedure. Fibre-based endomicroscopy and two types of viewer software will be used to detect FIB ONE signal in the lung.

OTHER

AZD1236

AZD1236 will be delivered at microdose concentrations and is thus considered to be unable to exert any pharmacologic effect outside the area of administration and unlikely to cause an adverse reaction.

Sponsors & Collaborators

• NHS Lothian

  collaborator OTHER_GOV

• University of Edinburgh

  lead OTHER

Principal Investigators

• Kev Dhaliwal, MBChB · University of Edinburgh

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• United Kingdom

Study Locations