An Online Repository for Pre-Clinical Imaging Protocols (PIPs).

Providing method descriptions that are more detailed than currently available in typical peer reviewed journals has been identified as an actionable area for improvement. In the biochemical and cell biology space, this need has been met through the creation of new journals focused on detailed protocols and materials sourcing. However, this format is not well suited for capturing instrument validation, detailed imaging protocols, and extensive statistical analysis.

Magnetic resonance biomarkers in radiation oncology: The report of AAPM Task Group 294.

A magnetic resonance (MR) biologic marker (biomarker) is a measurable quantitative characteristic that is an indicator of normal biological and pathogenetic processes or a response to therapeutic intervention derived from the MR imaging process. There is significant potential for MR biomarkers to facilitate personalized approaches to cancer care through more precise disease targeting by quantifying normal versus pathologic tissue function as well as toxicity to both radiation and chemotherapy. Both of which have the potential to increase the therapeutic ratio and provide earlier, more accurate monitoring of treatment response.

QIBA guidance: Computed tomography imaging for COVID-19 quantitative imaging applications.

As the COVID-19 pandemic impacts global populations, computed tomography (CT) lung imaging is being used in many countries to help manage patient care as well as to rapidly identify potentially useful quantitative COVID-19 CT imaging biomarkers. Quantitative COVID-19 CT imaging applications, typically based on computer vision modeling and artificial intelligence algorithms, include the potential for better methods to assess COVID-19 extent and severity, assist with differential diagnosis of COVID-19 versus other respiratory conditions, and predict disease trajectory. To help accelerate the development of robust quantitative imaging algorithms and tools, it is critical that CT imaging is obtained following best practices of the quantitative lung CT imaging community.

Incorporating radiomics into clinical trials: expert consensus endorsed by the European Society of Radiology on considerations for data-driven compared to biologically driven quantitative biomarkers.

Existing quantitative imaging biomarkers (QIBs) are associated with known biological tissue characteristics and follow a well-understood path of technical, biological and clinical validation before incorporation into clinical trials. In radiomics, novel data-driven processes extract numerous visually imperceptible statistical features from the imaging data with no a priori assumptions on their correlation with biological processes. The selection of relevant features (radiomic signature) and incorporation into clinical trials therefore requires additional considerations to ensure meaningful imaging endpoints.

Current and future cancer staging after neoadjuvant treatment for solid tumors.

Until recently, cancer registries have only collected cancer clinical stage at diagnosis, before any therapy, and pathological stage after surgical resection, provided no treatment has been given before the surgery, but they have not collected stage data after neoadjuvant therapy (NAT). Because NAT is increasingly being used to treat a variety of tumors, it has become important to make the distinction between both the clinical and the pathological assessment without NAT and the assessment after NAT to avoid any misunderstanding of the significance of the clinical and pathological findings. It also is important that cancer registries collect data after NAT to assess response and effectiveness of this treatment approach on a population basis.

The International Association for the Study of Lung Cancer Early Lung Imaging Confederation.

Purpose: To improve outcomes for lung cancer through low-dose computed tomography (LDCT) early lung cancer detection. The International Association for the Study of Lung Cancer is developing the Early Lung Imaging Confederation (ELIC) to serve as an open-source, international, universally accessible environment to analyze large collections of quality-controlled LDCT images and associated biomedical data for research and routine screening care.

Methods: ELIC is an international confederation that allows access to efficiently analyze large numbers of high-quality computed tomography (CT) images with associated de-identified clinical information without moving primary imaging/clinical or imaging data from its local or regional site of origin.

Task Group 174 Report: Utilization of [ F]Fluorodeoxyglucose Positron Emission Tomography ([ F]FDG-PET) in Radiation Therapy.

The use of positron emission tomography (PET) in radiation therapy (RT) is rapidly increasing in the areas of staging, segmentation, treatment planning, and response assessment. The most common radiotracer is F-fluorodeoxyglucose ([ F]FDG), a glucose analog with demonstrated efficacy in cancer diagnosis and staging. However, diagnosis and RT planning are different endeavors with unique requirements, and very little literature is available for guiding physicists and clinicians in the utilization of [ F]FDG-PET in RT.

Recommendations towards standards for quantitative MRI (qMRI) and outstanding needs.

5 Technical Efficacy: Stage 5 J. Magn. Reson.

Imaging biomarker roadmap for cancer studies.

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development.

Critical Review of Current Approaches for Echocardiographic Reproducibility and Reliability Assessment in Clinical Research.

Background: There is no broadly accepted standard method for assessing the quality of echocardiographic measurements in clinical research reports, despite the recognized importance of this information in assessing the quality of study results.

Methods: Twenty unique clinical studies were identified reporting echocardiographic data quality for determinations of left ventricular (LV) volumes (n = 13), ejection fraction (n = 12), mass (n = 9), outflow tract diameter (n = 3), and mitral Doppler peak early velocity (n = 4). To better understand the range of possible estimates of data quality and to compare their utility, reported reproducibility measures were tabulated, and de novo estimates were then calculated for missing measures, including intraclass correlation coefficient (ICC), 95% limits of agreement, coefficient of variation (CV), coverage probability, and total deviation index, for each variable for each study.

Statistical Issues in Testing Conformance with the Quantitative Imaging Biomarker Alliance (QIBA) Profile Claims.

A major initiative of the Quantitative Imaging Biomarker Alliance is to develop standards-based documents called "Profiles," which describe one or more technical performance claims for a given imaging modality. The term "actor" denotes any entity (device, software, or person) whose performance must meet certain specifications for the claim to be met. The objective of this paper is to present the statistical issues in testing actors' conformance with the specifications.

Do Radiologists Have Stage Fright? Tumor Staging and How We Can Add Value to the Care of Patients with Cancer.

With current shifts in our health care system and a growing national discussion around the concept of the value of imaging, it is time for radiologists and nuclear medicine physicians to recognize and accept our role in the multidisciplinary oncology team.

Metrology Standards for Quantitative Imaging Biomarkers.

Although investigators in the imaging community have been active in developing and evaluating quantitative imaging biomarkers (QIBs), the development and implementation of QIBs have been hampered by the inconsistent or incorrect use of terminology or methods for technical performance and statistical concepts. Technical performance is an assessment of how a test performs in reference objects or subjects under controlled conditions. In this article, some of the relevant statistical concepts are reviewed, methods that can be used for evaluating and comparing QIBs are described, and some of the technical performance issues related to imaging biomarkers are discussed.

Role of the Quantitative Imaging Biomarker Alliance in optimizing CT for the evaluation of lung cancer screen-detected nodules.

The Quantitative Imaging Biomarker Alliance (QIBA) is a multidisciplinary consortium sponsored by the RSNA to define processes that enable the implementation and advancement of quantitative imaging methods described in a QIBA profile document that outlines the process to reliably and accurately measure imaging features. A QIBA profile includes factors such as technical (product-specific) standards, user activities, and relationship to a clinically meaningful metric, such as with nodule measurement in the course of CT screening for lung cancer. In this report, the authors describe how the QIBA approach is being applied to the measurement of small pulmonary nodules such as those found during low-dose CT-based lung cancer screening.

Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.

Technological developments and greater rigor in the quantitative measurement of biological features in medical images have given rise to an increased interest in using quantitative imaging biomarkers to measure changes in these features. Critical to the performance of a quantitative imaging biomarker in preclinical or clinical settings are three primary metrology areas of interest: measurement linearity and bias, repeatability, and the ability to consistently reproduce equivalent results when conditions change, as would be expected in any clinical trial. Unfortunately, performance studies to date differ greatly in designs, analysis method, and metrics used to assess a quantitative imaging biomarker for clinical use.

Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.

Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker (QIB) techniques, little attention has been paid to the validation and comparison of the computer algorithms that implement the QIB measurements. In this paper we provide a framework for QIB algorithm comparisons.

The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions.

The development and implementation of quantitative imaging biomarkers has been hampered by the inconsistent and often incorrect use of terminology related to these markers. Sponsored by the Radiological Society of North America, an interdisciplinary group of radiologists, statisticians, physicists, and other researchers worked to develop a comprehensive terminology to serve as a foundation for quantitative imaging biomarker claims. Where possible, this working group adapted existing definitions derived from national or international standards bodies rather than invent new definitions for these terms.

The imaging viewpoint: how imaging affects determination of progression-free survival.

Tumor measurements on computed tomgoraphic or MRI scans and/or the appearance of new lesions on any of a variety of imaging studies including positron emission tomographic scans are key determinants for assessing progression-free survival as an endpoint in many clinical trials of therapies for solid tumors. Test-retest tumor measurement reproducibility may vary considerably across serial scans on the same patient unless rigorous attention is paid to standardization of image acquisition parameters and unless measurements are made by trained, experienced observers using validated objective methods. Target lesion selection also must be done with care to choose lesions that are or will be reproducibly measurable.

American Cancer Society lung cancer screening guidelines.

Findings from the National Cancer Institute's National Lung Screening Trial established that lung cancer mortality in specific high-risk groups can be reduced by annual screening with low-dose computed tomography. These findings indicate that the adoption of lung cancer screening could save many lives. Based on the results of the National Lung Screening Trial, the American Cancer Society is issuing an initial guideline for lung cancer screening.

A collaborative enterprise for multi-stakeholder participation in the advancement of quantitative imaging.

Medical imaging has seen substantial and rapid technical advances during the past decade, including advances in image acquisition devices, processing and analysis software, and agents to enhance specificity. Traditionally, medical imaging has defined anatomy, but increasingly newer, more advanced, imaging technologies provide biochemical and physiologic information based on both static and dynamic modalities. These advanced technologies are important not only for detecting disease but for characterizing and assessing change of disease with time or therapy.

Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.

Unlabelled: Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most efficiently, given the time- and cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the definition, validation, and qualification of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers.