Index of content:
Volume 34, Issue 6, June 2007
- President's Symposium: Auditorium
- Imaging as a Biomarker for Therapy Response
MO‐C‐AUD‐00 — Introduction: Imaging as a Biomarker for Therapy Response: Challenges, Opportunities and Initiatives34(2007); http://dx.doi.org/10.1118/1.2761205View Description Hide Description
Imaging as a biomarker for drug and radiation therapy response is emerging as an important area of research. The NIH has formed a Biomarker Consortium with several agencies of the federal government to leverage NIH and Industry funds to develop standardized methods for biomarkers that includes imaging. (http://www.fnih.org/Biomarkers%20Consortium/Biomarkers_home.shtml). The role of imaging as a biomarker poses unique problems for image data collection and analysis across different imaging platforms, as the latter factors increase the uncertainty of measurement, (NIST workshop agenda and report: http://usms.nist.gov/workshops/bioimaging.htm). The AAPM is well positioned to address standards for quality assurance for all imaging modalities, system performance, and development of clinical decision software tools for measurement of therapy response. For this symposium, speakers will discuss:
The role of imaging as a biomarker,
• Potential funding sources for this work at NIH,
• Leveraging therapy physics experience in the NCI's Radiation Research Program that can be applied to measurement of therapy response,
• How imaging societies can become engaged to address this research area and promote more standardized methods for biomedical imaging.
34(2007); http://dx.doi.org/10.1118/1.2761206View Description Hide Description
Radiologic images have been used for decades to gauge the effectiveness of various therapeutic interventions. In the areas of oncology, cardiovascular disease, neurology, arthritis and osteoporosis, imaging plays a vital role in decision‐making regarding effectiveness of therapy for an individual patient. Increasingly, imaging also is being utilized during all phases of therapeutic drug development, resulting in speedier drug discovery and, in some instances, ensuring a drug's safety. There has been an “explosion” in use of biomarkers in drug discovery.
Many imaging biomarkers are already commonly used, such as tumor size measured at CT to reflect tumor burden;T2 hyperintensity detected at brain MR imaging to reflect the burden of Multiple Sclerosis; and bone density determined on DEXA studies to assess for osteoporosis. One major benefit of imaging biomarkers is that the findings may be evaluated and quantified for changes over time. Newer imaging biomarkers are also playing a role in drug discovery, such as dynamic contrast‐enhanced MR imaging to assess for vascular flow to tumors; molecular imaging in the functional evaluation of cardiac, neurologic and oncologic processes; and CT in the evaluation of cystic fibrosis. The complexity in imaging biomarkers is increasing not only with the number of available imaging and post‐processing techniques, but perhaps even more importantly, with the number and diversity of relevant therapeutic options. Increasingly, it is becoming clear that a single imaging biomarker alone can be misleading, but is more robust when combined with other imaging or non‐imaging biomarkers.
1. Understand the role of imaging in monitoring response to therapy.
2. Understand the issues and clinical complications of imaging as a biomarker.
Research sponsored by Astrazeneca Corporation.
34(2007); http://dx.doi.org/10.1118/1.2761207View Description Hide Description
The NIH mission to improve the public health through biomedical research is accomplished by conducting research directly, by funding research through grants and contracts, and increasingly by partnering with any of a wide variety of partners. The synergy possible through the leveraging of NIH resources with the strengths of industry, professional societies, patient advocacy organizations, and academic partners allows work that cannot be done by any of the partners alone to be realized. Moreover, partnership can also facilitate increasing efficiency, economy and speed for translation of discovery to the public. The NIH Roadmap Public‐Private Partnership(PPP) Program is the center of such activities and policies, programs and examples of PPPs will be described, as well as ways that AAPM might take advantage of partnership opportunities.
1. Understand the NIH position on PPPs.
2. Understand PPP Policies and programs.
3. Learn how new PPPs can be initiated.
34(2007); http://dx.doi.org/10.1118/1.2761208View Description Hide Description
34(2007); http://dx.doi.org/10.1118/1.2761209View Description Hide Description
Imaging societies and members have a major stake in quantitative imaging and imaging biomarkers, because of what the future demands of us, and what we can do to help develop the field.
Imaging advances continue to heap increasing volumes of data on clinical imagers, creating pressure to improve workflow, accuracy of lesion detection and classification, and reporting and communication. Though some view the commoditization of medical imaging as inevitable, the new generation of imaging experts will add value to personalized medicine through quantitative imaging by sorting responders from non‐responders before treatment, rapidly assessing response to therapy already initiated, verifying targeting of “theragnostics”, measuring response to therapy, and rendering prognostic information. Clinical trialists will provide image data that meets surrogacy criteria for therapeutic response, thereby helping to streamline approval of new drugs and biologics.
Much will be required to achieve the aforementioned, including: harmonized image acquisition protocols; validated software algorithms for detection, classification, and measurement of therapeutic response; hardware and software standards for diagnosticimaging and image‐guided intervention; validated reference imagedatabases for testing algorithms and benchmarking performance; a standardized ontology such as RadLex; and structured reporting. In addition, a massive culture shift in training and practice will be required, to leave behind the era of qualitative interpretation, pattern recognition, and apprenticeship in favor of standardized methods, quantitative analysis, and robust informatics. Only in this way will clinical imagers add value and contribute to personalized medical decision making.
Professional societies, only one of many stakeholders, can do a great deal to advance quantitative imaging and the qualification of imaging biomarkers. Society meetings can serve to convene the stakeholders for updates, dialogue and planning. Annual meetings can provide a forum for presentations on the latest science in imaging biomarkers. Efforts to reduce measurement uncertainty can be and are being conducted by the various specialty societies. Additional coordination may serve an important accelerating purpose. Imaging biomarkers qualification will demand special focus on methodology. Societies can organize workshops to address the most important methodological questions and publish the proceedings. In addition, professional societies can help to facilitate the development of consensus standards among industry stakeholders. Societies may also be able to play a role in training and qualifying clinical trialists and imaging scientists, and organizing teams of qualified trialists to conduct clinical trials with imaging endpoints. Finally, societies can provide infrastructure and tools that enable the conduct of trials, and can help internationalize all imaging biomarkers efforts.
In summary, quantitative methods are vital to the future of medical imaging, research, informatics, and personalized medicine.Imaging professionals must adjust to add value, and training programs must transform. Professional imaging societies can play several extremely important roles in the advancement of quantitative imaging and imaging biomarkers.
1. Envision the quantitative imaging departments and training programs of the future, a future in which personalized medicine will demand added value from imaging professionals;
2. Know at least eight ways in which societies can contribute to the advancement of quantitative imaging and imaging biomarkers.