Medical Imaging In Clinical Trials

In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. More recently this has culminated in a number of inter-disciplinary meetings with the various stake holders, including the FDA. Changes in the regulatory process has resulted, when it comes to the submission of data to the FDA, in a therapeutic agent where one or more of the trial end-points is the assessment of a radiological end-point. No longer is it sufficient to have the images read by the local investigator site. The FDA has also identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials. As the pharmaceutical, biotech and medical device industry continues to identify ways to improve and speed up product development, medical imaging plays a more significant role. An understanding of the methodology and the metrics is therefore required but difficult to ascertain in one easy to read volume for individuals entering this field. This book will therefore fulfill this void, be it for the pharmaceutical personnel from medical director to monitor, or the Principal Investigator who is having to understand the complexities of the imaging and why it is having to be sent off-site for a 'central read.'

Handbook for Clinical Trials of Imaging and Image-Guided Interventions is the first single-source, multi-disciplinary reference, based on the didactic sessions presented at the annual ‘Clinical Trials Methodology Workshop’ for radiologists, radiation oncologists and imaging scientists (sponsored by the Radiological Society of North America (RSNA)). It focuses on educating radiologists, radiation oncologists and those involved in imaging research with how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers. The internationally renowned contributors take a broad approach, starting with principles of technology assessment, and then move into specific topics covering the clinical trials of therapy and clinical research in imaging guided interventions including radiotherapy. They discuss the use of imaging as a predictor of therapeutic response, screening trial design, and the practicalities of how to run an efficient clinical trial and good working practices. Later chapters provide a comprehensive array of quantitative methods including: an introduction to statistical considerations in study design, biostatistical analysis methods and their role in clinical imaging research, methods for quantitative imaging biomarker studies, and an introduction to cost effectiveness analysis. Handbook for Clinical Trials of Imaging and Image-Guided Interventions will educate and prepare radiologists at all levels and in all capacities in planning and conducting clinical imaging trials.

This monograph examines the contribution of imaging modalities to the stages of drug discovery and development, from early target validation to their use in clinical development programs. Chapters are devoted to the description of the drug discovery process, to the various imaging modalities preclinically and clinically, to applications of imaging during the optimization of a lead compound, addressing issues such as bioavailability and efficacy, and during drug safety evaluation.

Advances in Computerized Analysis in Clinical and Medical Imaging book is devoted for spreading of knowledge through the publication of scholarly research, primarily in the fields of clinical & medical imaging. The types of chapters consented include those that cover the development and implementation of algorithms and strategies based on the use of geometrical, statistical, physical, functional to solve the following types of problems, using medical image datasets: visualization, feature extraction, segmentation, image-guided surgery, representation of pictorial data, statistical shape analysis, computational physiology and telemedicine with medical images. This book highlights annotations for all the medical and clinical imaging researchers’ a fundamental advances of clinical and medical image analysis techniques. This book will be a good source for all the medical imaging and clinical research professionals, outstanding scientists, and educators from all around the world for network of knowledge sharing. This book will comprise high quality disseminations of new ideas, technology focus, research results and discussions on the evolution of Clinical and Medical image analysis techniques for the benefit of both scientific and industrial developments. Features: Research aspects in clinical and medical image processing Human Computer Interaction and interface in imaging diagnostics Intelligent Imaging Systems for effective analysis using machine learning algorithms Clinical and Scientific Evaluation of Imaging Studies Computer-aided disease detection and diagnosis Clinical evaluations of new technologies Mobility and assistive devices for challenged and elderly people This book serves as a reference book for researchers and doctoral students in the clinical and medical imaging domain including radiologists. Industries that manufacture imaging modality systems and develop optical systems would be especially interested in the challenges and solutions provided in the book. Professionals and practitioners in the medical and clinical imaging may be benefited directly from authors’ experiences.

50 Imaging Studies Every Doctors Should Know presents key studies that have shaped the practice of radiology. Selected using a rigorous methodology, the studies cover topics including: headache, back pain, chest pain, abdominal and pelvic pain, bone, joint, and extremity pain, cancer screening and management, and radiation exposure from medical imaging. For each study, a concise summary is presented with an emphasis on the results and limitations of the study, and its implications for practice. An illustrative clinical case and radiologic image conclude each review, followed by brief information on other relevant studies. This book is a must-read for health care professionals and anyone who wants to learn more about the data behind clinical practice.

Research Methods in Radiology provides concise, practical insights on how to design clinical and experimental studies in diagnostic imaging. This unique resource encompasses contributions from leaders in academic radiology as well as top epidemiologists, biostatisticians, and librarians with vast multidisciplinary and radiology research experience. The material reflects years of expertise teaching core biostatistics in radiology principles to residents, fellows, radiologists, and epidemiologists. Given the vast amount of published information on research methodology and statistics in radiology, the authors' goal was to write a high-yield review and study tool rather than a comprehensive book. Key topics are succinctly addressed in each chapter, including measurements in radiology; decision analysis in radiology; and systemic reviews, evidence-based imaging, and knowledge translation. Online exercises related to each topic enable residents to prepare for radiology board examinations and research radiologists to apply knowledge to clinical studies. Key Highlights Introductory chapters on analysis of diagnostic tests, linear and logistic regression, meta-analysis, statistical inference, and economic evaluation provide easy-to-follow tutorials Each chapter includes learning objectives, basic concepts, supplementary tables, and ancillary online material Case studies with images, graphs, and tables highlight primary "take home" points Sample size calculations are illustrated for a wide range of research questions Code is included for use in R, free open-source software for statistical analysis This book is an indispensable review of research methodology for radiology students and residents. Practicing clinicians will also benefit from this precisely focused reference tool on clinical and experimental research.

Advances in Computerized Analysis in Clinical and Medical Imaging book is devoted for spreading of knowledge through the publication of scholarly research, primarily in the fields of clinical & medical imaging. The types of chapters consented include those that cover the development and implementation of algorithms and strategies based on the use of geometrical, statistical, physical, functional to solve the following types of problems, using medical image datasets: visualization, feature extraction, segmentation, image-guided surgery, representation of pictorial data, statistical shape analysis, computational physiology and telemedicine with medical images. This book highlights annotations for all the medical and clinical imaging researchers’ a fundamental advances of clinical and medical image analysis techniques. This book will be a good source for all the medical imaging and clinical research professionals, outstanding scientists, and educators from all around the world for network of knowledge sharing. This book will comprise high quality disseminations of new ideas, technology focus, research results and discussions on the evolution of Clinical and Medical image analysis techniques for the benefit of both scientific and industrial developments. Features: Research aspects in clinical and medical image processing Human Computer Interaction and interface in imaging diagnostics Intelligent Imaging Systems for effective analysis using machine learning algorithms Clinical and Scientific Evaluation of Imaging Studies Computer-aided disease detection and diagnosis Clinical evaluations of new technologies Mobility and assistive devices for challenged and elderly people This book serves as a reference book for researchers and doctoral students in the clinical and medical imaging domain including radiologists. Industries that manufacture imaging modality systems and develop optical systems would be especially interested in the challenges and solutions provided in the book. Professionals and practitioners in the medical and clinical imaging may be benefited directly from authors’ experiences.

The visual representation of the interior of the human body for the purpose of clinical analysis and for the diagnosis and treatment of diseases is achieved through medical imaging. It also allows the understanding of normal physiology and anatomy. Some medical imaging techniques are magnetic resonance imaging (MRI), endoscopy, positron emission tomography (PET), medical ultrasonography, etc. Volume rendering techniques are used to provide a 3D visualization of the body or region of the body under study. Imaging techniques such as MRI and PET are typically used in neuroscience and oncology. Medical imaging may be used also to gain insight into complications in pregnancy, routine prenatal care and intercurrent diseases. Medical imaging is also a major tool in clinical trials as it allows quick visualization and assessment. The topics covered in this extensive book deal with the clinical applications of medical imaging. It aims to present researches that have transformed this discipline and aided its advancement. This book is a vital tool for all researching or studying this discipline as it gives incredible insights into emerging trends and concepts.