Serac Healthcare and the University of Exeter have initiated a Phase 2 clinical trial to investigate the potential of 99mTc-maraciclatide, a novel molecular imaging agent, in predicting the progression of interstitial lung disease (ILD). The PREDICT-ILD study aims to assess the effectiveness of quantitative computed tomography (CT) and 99mTc-maraciclatide in detecting and predicting ILD progression, potentially improving treatment strategies for this group of irreversible conditions.
The PREDICT-ILD study, recruiting at three NHS sites in the south-west of England, will compare the uptake of 99mTc-maraciclatide between participants with idiopathic pulmonary fibrosis (IPF), non-IPF fibrosing-ILD, and healthy controls. A total of 69 participants will be recruited, with 15 involved in the sub-study evaluating 99mTc-maraciclatide.
Imaging ILD Progression
Interstitial lung diseases, affecting over 150,000 people in the UK and causing approximately 1% of all deaths, are characterized by lung scarring (fibrosis). The unpredictable nature of ILD progression poses significant challenges in prognostication and drug development. Current diagnostic limitations hinder the selection of appropriate treatments, with some medications effective for inflammation potentially detrimental in patients with fibrotic disease.
"The distinction between ILD conditions which are characterised by scarring and inflammation is crucial as this determines the appropriate treatment," said David Hail, Chief Executive of Serac Healthcare. "A molecular imaging marker with the potential to differentiate between early-stage inflammation and the fibrosis it causes could have a significant impact on improving patient outcomes, as well as the development of new therapies."
Study Objectives and Endpoints
The primary objective of the PREDICT-ILD sub-study is to evaluate the feasibility of using 99mTc-maraciclatide to assess disease activity by comparing its uptake in different participant groups. Secondary endpoints include assessing the imaging agent's ability to identify αvβ3 activity and predict disease progression in fibrosing ILD patients.
Professor Michael Gibbons, Senior Investigator Fellow at the NIHR Exeter Biomedical Research Centre and Consultant Respiratory Physician, emphasized the potential impact of the study: "Being able to detect disease progression sooner and thereby enabling earlier access to disease modifying treatments to appropriate patients would represent a step change in the treatment of this incurable condition. We are excited to be working with Serac Healthcare to evaluate whether maraciclatide could play a part to bring precision medicine to this patient population."
99mTc-maraciclatide: A Novel Imaging Agent
99mTc-maraciclatide is a radio-labelled tracer that binds with high affinity to αvβ3 integrin, a cell-adhesion molecule upregulated on activated vascular endothelial cells, activated macrophages, and osteoclasts. Previous studies have demonstrated its ability to image inflammation in patients with rheumatoid arthritis, showing a high correlation between maraciclatide uptake and power Doppler ultrasound images in inflamed synovium.
