Special Report on the Consensus QIBA Profile for Objective Analytical Validation of Non-calcified and High-risk Plaque and Other Biomarkers using Computed Tomography Angiography

Andrew J Buckler; Suhny Abbara; Matthew J Budoff; John Jeffrey Carr; Carlo N De Cecco; J Kevin DeMarco; Maros Ferencik; Gemma A Figtree; Ichiro Ikuta; Márton Kolossváry; Mathis Konrad; Brajesh K Lal; Hugo Marques; Alastair J Moss; Nancy A Obuchowski; Edwin J R van Beek; Renu Virmani; Michelle C Williams; Luca Saba; U Joseph Schoepf

doi:10.1016/j.acra.2024.07.014

Special Report on the Consensus QIBA Profile for Objective Analytical Validation of Non-calcified and High-risk Plaque and Other Biomarkers using Computed Tomography Angiography

Acad Radiol. 2024 Jul 26:S1076-6332(24)00448-3. doi: 10.1016/j.acra.2024.07.014. Online ahead of print.

Authors

Andrew J Buckler¹, Suhny Abbara², Matthew J Budoff³, John Jeffrey Carr⁴, Carlo N De Cecco⁵, J Kevin DeMarco⁶, Maros Ferencik⁷, Gemma A Figtree⁸, Ichiro Ikuta⁹, Márton Kolossváry¹⁰, Mathis Konrad¹¹, Brajesh K Lal¹², Hugo Marques¹³, Alastair J Moss¹⁴, Nancy A Obuchowski¹⁵, Edwin J R van Beek¹⁶, Renu Virmani¹⁷, Michelle C Williams¹⁸, Luca Saba¹⁹, U Joseph Schoepf²⁰

Affiliations

¹ BBMSC, Boston, Massachusetts, USA (A.J.B.). Electronic address: [email protected].
² UT Southwestern, Dallas, Texas, USA (S.A.).
³ Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California, USA (M.J.B.).
⁴ Vanderbilt University Medical Center, Nashville, Tennessee, USA (J.J.C.).
⁵ Emory University, Atlanta, Georgia, USA (C.N.D.C., M.C.W.).
⁶ Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA (J.K.D.).
⁷ Oregon Health & Science University, Portland, Oregon, USA (M.F.).
⁸ Department of Cardiology, Royal North Shore Hospital, St Leonards, NSW, Australia (G.A.F.); Cardiovascular Discovery Group, Kolling Institute of Medical Research, St Leonards, Australia (G.A.F.); Faculty of Medicine & Health, University of Sydney, Camperdown, Royal North Shore Hospital, St Leonards, NSW, Australia (G.A.F.).
⁹ Mayo Clinic Arizona, Phoenix, Arizona, USA (I.I.).
¹⁰ Gottsegen National Cardiovascular Center, Budapest, Hungary (M.K.); Physiological Controls Research Center, University Research and Innovation Center, Óbuda University, Budapest, Hungary (M.K.).
¹¹ Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany (M.K.).
¹² Department of Vascular Surgery, University of Maryland, Baltimore, Maryland, USA (B.K.L.); Vascular Service, VA Medical Center, Baltimore, Maryland, USA (B.K.L.).
¹³ Hospital da Luz, Imaging Department - Católica Medical School, Lisboa, Portugal (H.M.).
¹⁴ Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Centre, University of Leicester, Leicester, UK (A.J.M.).
¹⁵ Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio, USA (N.A.O.).
¹⁶ Edinburgh Imaging, University of Edinburgh, Scotland (E.J.R.V.B.).
¹⁷ CV Path Institute, Gaithersburg, Maryland, USA (R.V.).
¹⁸ Emory University, Atlanta, Georgia, USA (C.N.D.C., M.C.W.); Centre for Cardiovascular Science, University of Edinburgh, Scotland (M.C.W.).
¹⁹ University of Cagliari, Sardinia, Italy (L.S.).
²⁰ Medical University of South Carolina, Charleston, South Carolina, USA (U.J.S.).

PMID: 39060206
DOI: 10.1016/j.acra.2024.07.014

Abstract

Rationale and objectives: Evidence is building in support of the clinical utility of atherosclerotic plaque imaging by computed tomography angiography (CTA). There is increasing organized activity to embrace non-calcified plaque (NCP) as a formally defined biomarker for clinical trials, and high-risk plaque (HRP) for clinical care, as the most relevant measures for the field to advance and worthy of community efforts to validate. Yet the ability to assess the quantitative performance of any given specific solution to make these measurements or classifications is not available. Vendors use differing definitions, assessment metrics, and validation data sets to describe their offerings without clinician users having the capability to make objective assessments of accuracy and precision and how this affects diagnostic confidence.

Materials and methods: The QIBA Profile for Atherosclerosis Biomarkers by CTA was created by the Quantitative Imaging Biomarkers Alliance (QIBA) to improve objectivity and decrease the variability of noninvasive plaque phenotyping. The Profile provides claims on the accuracy and precision of plaque measures individually and when combined.

Results: Individual plaque morphology measurements are evaluated in terms of bias (accuracy), slope (consistency of the bias across the measurement range, needed for measurements of change), and variability. The multiparametric plaque stability phenotype is evaluated in terms of agreement with expert pathologists. The Profile is intended for a broad audience, including those engaged in discovery science, clinical trials, and patient care.

Conclusion: This report provides a rationale and overview of the Profile claims and how to comply with the Profile in research and clinical practice.

Summary statement: This article summarizes objective means to validate the analytical performance of non-calcified plaque (NCP), other emerging plaque morphology measurements, and multiparametric histology-defined high-risk plaque (HRP), as outlined in the QIBA Profile for Atherosclerosis Biomarkers by CTA.

Keywords: Atherosclerosis; Guidelines; High-risk plaque; Multiparametric biomarker; Non-calcified plaque; Plaque imaging; Profile; Quantitative imaging biomarkers.