PREDICT-ILD

• Research type

  Research Study

• Full title

  PRospective Evaluation of Interstitial Lung DIsease progression with quantitative CT (PREDICT-ILD)

• IRAS ID

  319752

• Contact name

  Giles Dixon

• Contact email

  gd426@exeter.ac.uk

• Sponsor organisation

  University of Exeter

• Clinicaltrials.gov Identifier

  NCT05609201

• Duration of Study in the UK

  1 years, 5 months, 30 days

• Research summary

  The interstitial lung diseases (ILD) are a heterogenous group of conditions with varying degrees of inflammation and scarring (fibrosis) of the lungs. ILD progression is unpredictable, making prognostication challenging. A proportion of patients will develop inexorably progressive disease termed progressive fibrosing ILD (PF-ILD).

  We will undertake a feasibility study to determine whether baseline and longitudinal quantitative assessment of high-resolution CT scans (HRCT) can predict and quantify disease progression in fibrotic-ILD.

  We will also assess the role of several new ways of predicting and monitoring disease progression including:

  • Assessment of the endothelial glycocalyx (EG), a mesh-like layer that lines the small blood vessels, which has been implicated in non-thoracic fibrotic diseases.
  • Measurement of white blood cell telomere lengths; telomeres are repetitive genetic sequences which cap chromosomes which are shortened in a wide range of ILDs.
  • A digital stethoscope assessment which records and analyses breath sounds

  36 adult participants with fibrotic-ILD and 18 healthy volunteers from 3 centres in England will be recruited. Case (disease) participants will undergo investigations at 0, 6 and 12 months from recruitment including:

  1. HRCT
  2. Lung function testing
  3. EG, telomere length and digital stethoscope assessment
  4. Health related quality of life assessments

  Healthy controls will undergo the investigations in point 3.

  The primary outcome will assess the correlation of disease progression status measured by standard of care (FVC) with baseline qCT, telomere and EG assessment. Feasibility outcomes will be assessed including recruitment, consent and attrition rates.

  The results will inform a subsequent multi-centre study to assess the clinical benefit of disease monitoring with the measures assessed in this study.

  15 participants will be invited to a sub-study to investigate the role of a specialised scan (SPECT-CT scan) to identify patients at risk of disease progression.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  23/NW/0009

• Date of REC Opinion

  21 Feb 2023

• REC opinion

  Further Information Favourable Opinion