Imaging Biomarkers Of Treatment Response PDF Download
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| Author | : |
| Publisher | : |
| Total Pages | : 294 |
| Release | : 2015 |
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Download Imaging Biomarkers of Treatment Response Book in PDF, ePub and Kindle
Quantitative imaging biomarkers -- numerical measurements derived from medical imaging that can be interpreted by clinicians - are a critical component of treatment response assessment in oncology. They can also play an important role in the design and interpretation of clinical trials, provided that they are measured following a standardized set of best practices. In this thesis, we have demonstrated the successful application of imaging biomarkers of treatment response to a clinical trial assessing the pharmacodynamics and pharmacokinetics of the anti-angiogenic TKI therapeutic Axitinib. We have illustrated the challenges facing quantitative imaging biomarkers in general, and gained valuable insights into anti-angiogenic therapy in particular. We have characterized the pharmacodynamics of "withdrawal flare," a rapid increase in tumor proliferation following cessation of anti-angiogenic therapy, using quantitative imaging biomarkers derived from FLT PET. This is the first time in humans that the temporal dynamics of Axitinib withdrawal flare have been characterized, a critical step in optimizing the use of this drug in combination therapy. Although we demonstrated that significant flare occurs in patients treated with Axitinib, we also observed substantial inter-patient heterogeneity in imaging response during withdrawal. Among the sub-set of patients experiencing withdrawal flare, it was found to occur at two days post-cessation of Axitinib, with relatively little additional flare between days 2 and 7 of withdrawal. Moreover, withdrawal flare was found to be associated with poor clinical outcome. We directly compared the results of the Axitinib trial with an earlier trial of a related anti-angiogenic drug, Sunitinib, which had used the same imaging biomarkers of treatment response. The proliferative and vascular response during withdrawal of Axitinib and Sunitinib was found to be nearly identical, and there is not sufficient evidence to support any significant difference in proliferative response during treatment. We also explored intra-patient, inter-lesion response heterogeneity. However, when comparing the imaging response with pre-treatment phenotypes, no significant correlations were observed, suggesting that some underlying biological mechanisms may be driving the inter-lesion differences in response. The insights gained from this original work support several hypotheses for how to improve patient treatment. These hypotheses will be partially addressed in three new ongoing clinical trials at the University of Wisconsin.
| Author | : P. Scully |
| Publisher | : |
| Total Pages | : |
| Release | : 2015 |
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| ISBN | : |
Download Imaging Biomarkers of Treatment Response: Applications to Clinical Trials Book in PDF, ePub and Kindle
| Author | : Luis Martí-Bonmatí |
| Publisher | : Springer |
| Total Pages | : 313 |
| Release | : 2016-11-03 |
| Genre | : Medical |
| ISBN | : 3319435043 |
Download Imaging Biomarkers Book in PDF, ePub and Kindle
This is the first book to cover all aspects of the development of imaging biomarkers and their integration into clinical practice, from the conceptual basis through to the technical aspects that need to be considered in order to ensure that medical imaging can serve as a powerful quantification instrument capable of providing valuable information on organ and tissue properties. The process of imaging biomarker development is considered step by step, covering proof of concept, proof of mechanism, image acquisition, image preparation, imaging biomarker analysis and measurement, detection of measurement biases (proof of principle), proof of efficacy and effectiveness, and reporting of results. Sources of uncertainty in the accuracy and precision of measurements and pearls and pitfalls in gold standards and biological correlation are discussed. In addition, practical use cases are included on imaging biomarker implementation in brain, oncologic, cardiovascular, musculoskeletal, and abdominal diseases. The authors are a multidisciplinary team of expert radiologists and engineers, and the book will be of value to all with an interest in the quantitative imaging of biomarkers in personalized medicine.
| Author | : Jennifer A. Hadley |
| Publisher | : |
| Total Pages | : 127 |
| Release | : 2014 |
| Genre | : Antipsychotic drugs |
| ISBN | : |
Download Imaging Biomarkers for Prediction of Treatment Response in Schizophrenia Book in PDF, ePub and Kindle
Schizophrenia affects approximately 1% of the population and is one of the top five causes of disability worldwide. Patient response to any particular drug is variable and currently unpredictable. Our overall goal is to identify imaging biomarkers that will distinguish patients with schizophrenia who will respond to an antipsychotic drug from those who will not. When considering potential biomarkers, it is important to note that schizophrenia is known to involve altered neuronal connections, thought to reflect pathologically relevant changes associated with the disease. We propose to utilize functional connectivity as a biomarker for treatment response to antipsychotic drugs in schizophrenia. Our previous imaging studies have made significant progress by identifying several brain regions that show changes in blood flow in response to antipsychotic drugs. The proposed research will build upon this work, by examining differences in connectivity between these regions, using a region-based analysis, and globally, using a network-based analysis, at three time points in antipsychotic drug treatment: (1) in the medication-free, pre-treatment baseline state, (2) after one week of treatment, and (3) after six weeks of treatment.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 335 |
| Release | : 2010-06-25 |
| Genre | : Medical |
| ISBN | : 0309157277 |
Download Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Book in PDF, ePub and Kindle
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
| Author | : Christie Lin |
| Publisher | : |
| Total Pages | : 158 |
| Release | : 2018 |
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| ISBN | : |
Download Establishing 18F-NaF PET Quantitative Imaging Biomarkers for Treatment Response Assessment Book in PDF, ePub and Kindle
The use of functional imaging with positron emission tomography (PET) has increased in clinical oncology to assess response to therapy. Response assessment with PET scans is largely interpreted qualitatively, which results in subjective clinical evaluation. Alternatively, quantitative imaging can enable objective evaluation; however, the path to establish standardized response criteria of candidate quantitative imaging biomarkers (QIBs) is extremely challenging. This dissertation focused on establishing quantitative 18F-NaF PET-based treatment response assessment. Using 18F-NaF PET/CT scans of bone tumors (osseous lesions) in metastatic castration-resistant prostate cancer patients imaged in a multi-center clinical trial, we characterized test-retest repeatability of standardized uptake values (SUVs) measured from both lesions and patients, and reproducibility across imaging sites. From these studies we derived the limits of agreement, which can be interpreted as objective response criteria. To assess the generalizability of response criteria, we investigated sources of variability that may influence response assessment. Linear mixed effects models identified both differences in injected dose between scans and anatomical location of the lesion may influence repeatability. To address the need to mitigate potential variability in longitudinal imaging, we evaluated the utility of reference region normalization but found that SUVs were similarly robust without. In order to advance criteria for QIBs of response, we introduced the response-to-repeatability metric and discovered that not all candidate QIBs were able to discern statistically measurable changes at treatment follow-up. In our last study, we introduced a bootstrapping method to estimate sample size requirements needed to achieve a desired level of repeatability, a critical component in clinical trial design. Finally, we outlined statistical limitations to the generalizability of response criteria, which will guide appropriate implementation of imaging-based response assessment in the clinical routine. In summary, we present a statistical basis to enable quantitative imaging-based response criteria and methods to iteratively advance needs in both research and the clinic.
| Author | : Michael R. Bleavins |
| Publisher | : John Wiley & Sons |
| Total Pages | : 559 |
| Release | : 2011-09-20 |
| Genre | : Medical |
| ISBN | : 1118210425 |
Download Biomarkers in Drug Development Book in PDF, ePub and Kindle
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 354 |
| Release | : 2012-09-13 |
| Genre | : Science |
| ISBN | : 0309224187 |
Download Evolution of Translational Omics Book in PDF, ePub and Kindle
Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.
| Author | : Caroline Chung |
| Publisher | : |
| Total Pages | : 338 |
| Release | : 2011 |
| Genre | : |
| ISBN | : 9780494762431 |
Download Imaging Biomarkers of Response to Radiation and Anti-angiogenic Agents in Brain Tumors Book in PDF, ePub and Kindle
There is mounting evidence to support combined therapy with radiation (RT) and anti-angiogenic agents (AA) for the treatment of brain tumors. However, the therapeutic benefit of this combined treatment hinges on the specific dose, schedule, and duration of each treatment. Early biomarkers that reflect tumor physiological responses provide key information that could guide these aspects of treatment. Pre-clinical tumor models are invaluable tools for identifying potential biomarkers, their optimal timing for measurement and their ability to guide therapy in clinical translation. This thesis demonstrates the feasibility and potential of serial MRI to guide the design, delivery and measure of early response to combined AA and RT in a murine intracranial glioma model. We identified promising biomarker changes reflecting early treatment response that may ultimately facilitate individualized spatio-temporal delivery of radiotherapy (RT) and anti-angiogenic agents (AA) for brain tumors.
| Author | : Antonio Luna |
| Publisher | : Springer |
| Total Pages | : 918 |
| Release | : 2014-07-08 |
| Genre | : Medical |
| ISBN | : 3642405827 |
Download Functional Imaging in Oncology Book in PDF, ePub and Kindle
In the new era of functional and molecular imaging, both currently available imaging biomarkers and biomarkers under development are expected to lead to major changes in the management of oncological patients. This two-volume book is a practical manual on the various imaging techniques capable of delivering functional information on cancer, including diffusion MRI, perfusion CT and MRI, dual-energy CT, spectroscopy, dynamic contrast-enhanced ultrasonography, PET, and hybrid modalities. This second volume considers the applications and benefits of these techniques in a wide range of tumor types, including their role in diagnosis, prediction of treatment outcome, and early evaluation of treatment response. Each chapter addresses a specific malignancy and is written by one or more acclaimed experts. The lucid text is complemented by numerous high-quality illustrations that highlight key features and major teaching points.
