Lung Cancer Clinical Trial
— FIB ONEOfficial title:
Exploratory Clinical Study to Image the Intrapulmonary Microdosing of FIBroproliferation ONE (FIB ONE) Using Endomicroscopy
Verified date | February 2020 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: All Cohorts Capacity to provide informed consent - = 16 years - Attending consultant permission for bronchoscopy - Thoracic CT scan taken within the previous 10 weeks - Readily accessible target areas with bronchoscopy and FE - Cohort 1 - Patients with a suspected or confirmed lung condition associated with increased activity of the fibroproliferative pathway and scheduled to undergo an elective bronchoscopy - Cohort 2 - Patients undergoing planned cardiothoracic surgery for biopsy/resection of a lung condition associated with increased activity of the fibroproliferative pathway. Exclusion Criteria: - All Cohorts - Refusal for participation by attending consultant - Any history of anaphylaxis - Significant coagulopathy or bleeding tendency, 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The measurement of FIB ONE fluorescence intensity in the lung (Part A). | Quantify the change in fluorescence upon delivery of FIB ONE. | Analysis to take one week to complete post procedure. | |
Secondary | The measurement of FIB ONE fluorescence intensity in the lung in the presence of PBS or AZD1236 (Part B). | Quantify the change in fluorescence upon delivery of FIB ONE and AZD1236/PBS. | Analysis to take one week to complete post procedure. |
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