par Lee Nelson
, Contributing Reporter | April 27, 2017
A five-year, European research project launched recently to develop new CT and MR scan techniques that will examine the buildup of compounds caused by drugs used by arthritis and cancer patients.
The TRISTAN project (Translational Imaging in Drug Safety Assessment) involves more than 20 organizations across Europe. The University of Manchester in the U.K. is part of this new consortium and is receiving funding to develop scanning techniques for imaging biomarkers for drug-induced liver and lung diseases.
“Often, the risk of drug-induced lung injury is only discovered once a drug has reached the market,” Dr. Sarah Skeoch told HCB News. She is a National Institute for Health Research clinical lecturer in rheumatology, and leading this part of the research in Manchester.
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“Additionally, patients with conditions such as rheumatoid arthritis have a higher prevalence of interstitial lung disease (ILD) as a result of their arthritis," she said. "So in these patient groups it can be difficult to determine whether the drug or disease has triggered the new lung symptoms.”
Development of new imaging methods are needed to identify early signs of lung injury so that a drug can be stopped quickly, limiting the harm to the individual but also allowing drug developers to make earlier decisions to stop development of ones which pose significant risk.
Some of the things they hope to learn from the research include:
• Better ways to identify safety signals for lung injury with new medications
• Develop biomarkers, which can be used to interrogate the underlying mechanisms of both DI-ILD and other ILD subtypes to help us understand how the conditions develop and progress.
• Develop biomarkers that can provide information on severity of ILD and prognosis that could be used to guide treatment decisions.
“In clinical practice, imaging biomarkers with the ability to detect signs of disease progression could allow more prompt decisions about treatment,” Skeoch said. “The ability to discriminate between drug-induced and disease-related ILD would be invaluable both in clinical practice but also in the context of drug development in populations with a high burden of pre-existing disease-related ILD.”
The research and protocols for lung imaging will be published in open access journals so they can be available to other researchers and health care professionals to use. “We hope that the lung scans can be implemented in clinical practice in the future to aid diagnosis and management of patients with all types of interstitial lung disease,” she said.
This is an observational study, therefore patients will be looked after by their own doctor and no new medications are being tested. Patients will have breathing tests (spirometry), blood tests, CT and MR scans at inclusion and will have follow-up tests when their condition changes.
“We will then review patients up to a year later to see how their condition is. We can then examine whether changes on the initial scans they had can predict the course of their lung condition,” Skeoch added.