1.Our consortium has broad, deep experience of drug development and imaging biomarker (IB) validation. We are internationally recognized experts in transporter biology, animal models of lung injury, toxicology, DCEMRI, compartmental modeling, 1H&129Xe lung MR, and labeling of biologicals with PET and fluorescence tags, together with physicians who care for relevant patients. We have an outstanding record of translating IBs: (a) into animals, (b) into man, (c) into tools which drug developers use with confidence in clinical trials of investigational agents, (d) into regulatory drug development and healthcare. We will develop and validate the required IBs and make them commercially available.
2.Building on our previous work with gadoxetate DCEMRI IBs we will develop and standardise, define sensitivity and specificity in rats, and show valid and comparable data multicentre in human volunteers and patients.
3.We believe the search for IBs of Drug Induced Interstitial Lung Disease (DIILD) should start in DIILD patients. Cancer and rheumatology patients receiving, in their standard care, drugs with DIILD liability, and whose physicians withdraw the drug due to suspected DIILD, will be imaged when symptomatic and followed up. From this we will derive IBs of DIILD which predict outcome. We will also develop IBs from 1H/129Xe MRI and PET to further characterise DIILD, and will back-translate
and validate all these IBs in rat models.
4.To better assess biodistribution of biologics, we will thoroughly characterise two well-chosen exemplars in rats, pigs and humans: an antibody biologic and a peptide biologic. We will use 89Zr, 18F and 68Ga PET, fluorescence and MALDI imaging.
5.We will follow an imaging biomarker roadmap to establish (a) that the IBs can be deployed robustly in whatever centre they are needed, (b) the relationship of the IB to underlying biology, (c) how well the IB forecasts clinical outcome, and make appropriate arrangements for dissemination.
Deliverables
List of deliverables.
Free-breathing 3D acquisition protocol for pre-clinical MRI
Websites, patent fillings, videos etc.
2020-04-24 02:25:35
Manuscript on the progression of bleomycin induced inflammation and fibrosis in rats imaged by MRI/CT
Documents, reports
2020-04-24 02:25:35
Manuscript on novel 89Zr chelates for protein labeling
Documents, reports
2020-04-24 02:25:35
Manuscript for phantom imaging reproducibility
Documents, reports
2020-04-24 02:25:35
Manuscript for reviews on ILD imaging in humans
Documents, reports
2020-04-24 02:25:35
Free-breathing 3D acquisition protocol for clinical MRI
Websites, patent fillings, videos etc.
2020-04-24 02:25:35
Gadoxetate imaging model software
Websites, patent fillings, videos etc.
2020-04-24 02:25:35
Manuscript for a review on current 89Zr chelates for protein labeling
Documents, reports
2020-04-24 02:25:34
Review 1 for liver transporter assessment by imaging
Documents, reports
2020-04-24 02:25:34
Phantom QC for clinical MRI scanner stability over time
Websites, patent fillings, videos etc.
2020-04-24 02:25:34
optimized data acquisition of 129 Xe MRI
Websites, patent fillings, videos etc.
2020-04-24 02:25:34
Workplan for pre-clinical BSEP-probe evaluation
Documents, reports
2020-04-24 02:25:34
Phantom QC for rat MRI scanner stability over time
Sarah Skeoch, Nicholas Weatherley, Andrew Swift, Alexander Oldroyd, Christopher Johns, Conal Hayton, Alessandro Giollo, James Wild, John Waterton, Maya Buch, Kim Linton, Ian Bruce, Colm Leonard, Stephen Bianchi, Nazia Chaudhuri Drug-Induced Interstitial Lung Disease: A Systematic Review published pages: 356, ISSN: 2077-0383, DOI: 10.3390/jcm7100356
Journal of Clinical Medicine 7/10
2020-04-24
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Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.
Thanks. And then put a link of this page into your project's website.
The information about "IB4SD-TRISTAN" are provided by the European Opendata Portal: CORDIS opendata.
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