FIB ONE and Versicolour
Research type
Research Study
Full title
Exploratory clinical study to image the intrapulmonary microdosing of FIBroproliferation ONE (FIB ONE) using endomicroscopy
IRAS ID
193980
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
Fibrosis is a condition which renders tissue unable to heal back to normal and work effectively following either injury or a disease process. 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 we don’t fully understand the mechanisms of fibrosis and so therefore cannot monitor or treat these conditions as productively as we could.
In an effort to address this problem, the research team have designed and synthesised an imaging agent (FIB ONE) that can detect fibrosis in the lung. FIB ONE will be used at very low concentrations in patients with a lung condition characterised by excessive activity of the fibroproliferative pathway either scheduled for a routine bronchoscopy or elective surgery. FIB ONE will be administered directly into the lungs during a bronchoscopy procedure and images of the lungs will be analysed. As part of this study, the research team have also built a novel detection system (Versicolour) which will be used to detect the signal emitted from FIB ONE and this will be compared to equipment that is routinely used in the NHS when imaging the FIB ONE probe. Importantly, the only part in direct contact with the patients will be an approved and routinely used thin fibre optic probe passed down the bronchoscope. All patients will be monitored by the clinical research team for approximately 4-6 hours following dosing and blood samples will be taken during this time. All participants will be contacted 24 hours following the procedure to make sure that no problems were encountered.
REC name
South East Scotland REC 02
REC reference
15/SS/0235
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion