Press Release: Elucid Bioimaging Announces Initial Q-CAMP CT Study Results Exceed ExpectationsSeptember 18, 2017
Wenham, Massachusetts – Elucid Bioimaging is pleased to announce that the lipid necrotic core, calcification, and plaque matrix objectives of its Q-CAMP study (NCT02143102) have been met. Elucid’s vascuCAP® software analysis of carotid CT Angiography (CTA) exceeded company expectations with its high correlation and low bias in its measurements of lipid rich necrotic core (LRNC), calcifications, and plaque matrix compared to histology of the same tissue post-endarterectomy.
125 enrolled endarterectomy patients aged 43–85 years (average age, 64 years) with known atherosclerosis were enrolled, yielding 114 complete sets of data. Of these data, approximately one third were MRI and the other two thirds were CTA. Some patients had both MRI and CTA.
Data from the initial CTA group comprising the first 31 consecutive patients was used for development and validation of LRNC, calcification, and matrix measurements. This group yielded 239 cross sections with histologic examination which were hand matched to orthogonal cross-sections of artery from the CTA. Comparison between vascuCAP® cross sectional measurements of plaque components and histology showed low levels of bias and high Pearson correlation coefficients for calcification (-0.096 mm2 and 0.973, respectively), LRNC (1.26 mm2 and 0.856), and matrix (-2.44 mm2 and 0.885). Intra-reader variability and inter-reader variability were both low with repeatability coefficients ranging from 1.50 mm2 to 1.83 mm2 and 2.09 mm2 to 4.43 mm2 respectively among tissue characteristics. Data from the remaining patients with CTA are currently in-use for the development and validation of automatic plaque ulceration, cap thickness and calcium depth measurements.
Details of the study are available in “Atherosclerotic Plaque Tissue: Noninvasive Quantitative Assessment of Characteristics with Software-aided Measurements from Conventional CT Angiography,” available in the September edition of Radiology. Results data have also been submitted to clinicaltrials.gov.
This study demonstrates the strengths of the team we have assembled to develop vascuCAP® as well as the commitment to analytical validation we share with the Dr. Sheahan and the other investigators at LSU,” said Andrew Buckler, Founder and CTO, “we look forward to building on these results with research to demonstrate clinical benefits of this product.”
“This is an important milestone in the commercialization of our atherosclerosis analysis software.” remarked John Garber, CEO, “We anticipate plaque characterization to grow into a significant role in diagnostic and treatment decisions. This will only increase as additional measurements are added to vascuCAP®.”
About Elucid Bioimaging Inc.
Elucid is a biomedical engineering company with a unique portfolio of expertise at the crossroads of quantitative medical imaging, clinical trials, surrogate endpoints and big data to enable its Computer Aided Phenotyping® or CAP® diagnostics platform. Elucid’s first commercial product, vascuCAP® has been cleared for sale in the United States for the analysis of atheromatous lesions and their subcomponents from CTA data to enhance patient care. The Research Edition is available world-wide for customers performing research.
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