ImageILD (EORTC 1658-IG)

  • Research type

    Research Study

  • Full title

    Qualification of imaging methods to assess cancer drug induced interstitial lung disease (ImageILD)

  • IRAS ID

    247439

  • Contact name

    Julie Coupain

  • Contact email

    regulatory@eortc.org

  • Sponsor organisation

    European Organisation for the Research and Treatment of Cancer (EORTC)

  • Clinicaltrials.gov Identifier

    NCT03294746

  • Duration of Study in the UK

    3 years, 2 months, 15 days

  • Research summary

    Anti-cancer drugs are given to treat cancer, but can also have side effects, including damage to the lungs. An abnormal healing response can lead to lung inflammation and eventually scarring, making it difficult for oxygen to pass into the bloodstream. These abnormalities are called ‘drug-induced interstitial lung disease (DIILD)’. Over four hundred drugs are known to cause DIILD.

    Currently, the routine test to diagnose DIILD is a CT (computed tomography) scan of the chest. Results are interpreted with information about symptoms and drug history. CT images give useful information, but results are non-specific and so it isn’t always possible to make a reliable diagnosis of DIILD or to determine its severity. The purpose of this study is to test a standardised CT scoring system for the diagnosis and assessment of DIILD. If the scoring system is successful it may be adopted as a more reliable method of diagnosing DIILD.

    The study will recruit adult patients who develop suspected DIILD while on cancer treatment. They will have a series of CT scans and routine lung function tests (breathing tests). CT scans will be centrally reviewed and scored by the study radiologists and results compared with lung function tests to qualify the CT scoring method as a new diagnostic test. Patients will also undergo history and physical examinations, and complete study questionnaires. DIILD will be managed at the discretion of the treating physicians, however details and clinical outcomes will be collected by the study team along with results of clinical examinations, blood tests and other investigations.

    This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer).

  • REC name

    North West - Greater Manchester East Research Ethics Committee

  • REC reference

    18/NW/0506

  • Date of REC Opinion

    13 Sep 2018

  • REC opinion

    Further Information Favourable Opinion