An interventional study of Dabigatran and FDG PET scan in Idiopathic Pulmonary Fibrosis, IPF and Interstitial Lung Disease, sponsored by University College, London. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-09-01.
Sponsored by University College, London · Not applicable, Interventional, and Basic science
The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced as a result and is over expressed in IPF patients, so may be important in propagating disease activity. We aim to recruit patients with IPF and then complete FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans pre and post manipulation of the coagulation cascade to assess the role of this biological pathway in disease activity. Previous studies from our institution have demonstrated increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to date the cells and pathways responsible for this signal have not been identified and thus need further exploration.
Patients with IPF who meet all the inclusion criteria (and none of the exclusion criteria) will be assessed and invite to participate.
They will undergo baseline assessment with lung function, 6 minute walk test and health quality assessments.
Blood tests will assess the pro-coagulant state of these individuals. They will undergo a baseline FDG PET scan followed by manipulation of the coagulation cascade with 24 days (+/- 3 days) dabigatran. They will then complete a second FDG PET, health quality assessments and blood tests to demonstrate target engagement.
565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 12 is below the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
All patients will be entered into the arm, i.e. this is a single arm study. All patients will complete 2 FDG PET scans. All patients will receive dabigatran (direct thrombin inhibitor) at a dose of 110mg twice daily (oral). The drug will be given for 24 days (+/-3 days). The variation in duration reflects that scans are completed Monday to Friday only.
Drug: Dabigatran · Radiation: FDG PET scan
Anti-coagulant
Scan using PET combined with a high resolution CT scan (HRCT)
Demonstrate a change in FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) avidity
FDG avidity describes the degree of tissue uptake of the labelled glucose. It is a numerical continuous variable. It is calculated from the scan using several methods, manually on a workstation and using a mathematical modelling computer programme. The main number generated is called the standardised uptake value (SUV) and the higher the number the higher the metabolic activity in the area. The degree of activity will be quantified for each individual and compared with standard measures of disease activity i.e. lung function measures and quality of life questionnaires. For each individual the change in the SUV measure will be analysed from the scan performed before and then after manipulation of the coagulation cascade.
Time frame: Approximately 4 weeks
Demonstrate changes in various coagulation factors
This patient group have demonstrated a hyper coagulable state in a number of previous studies. We will demonstrate this using blood tests prior to administration of dabigatran. The coagulation markers (a blood test, many used in standard clinical practice) will be repeated during treatment to demonstrate target engagement.
Time frame: Approximately 4 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dabigatran
Idiopathic Pulmonary Fibrosis →