Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging in Oncology Clinical Trials.

The Uniform Protocols for Imaging in Clinical Trials (UPICT) (18)F-FDG PET/CT protocol is intended to guide the performance of whole-body FDG PET/CT studies within the context of single- and multiple-center clinical trials of oncologic therapies by providing acceptable (minimum), target, and ideal standards for all phases of imaging. The aim is to minimize variability in intra- and intersubject, intra- and interplatform, interexamination, and interinstitutional primary or derived data. The goal of this condensed version of the much larger document is to make readers aware of the general content and subject area. The document has several main subjects: context of the imaging protocol within the clinical trial; site selection, qualification, and training; subject scheduling; subject preparation; imaging-related substance preparation and administration; imaging procedure; image postprocessing; image analysis; image interpretation; archiving and distribution of data; quality control; and imaging-associated risks and risk management.

Challenges to deep brain stimulation: a pragmatic response to ethical, fiscal, and regulatory concerns.

In response to the early success of deep brain stimulation, we offer some common-sense strategies to sustain the work, addressing the need to do so in a fiscally workable, ethically transparent, and scientifically informed manner. After delineating major threats, we will suggest reforms in both the legislative and regulatory spheres that might remediate these challenges. We will recommend (1) revisions to the Bayh-Dole Act of 1980, which governs intellectual property exchange resulting from federally funded research; (2) revisions to the Association of American Medical Colleges recommendations concerning the management of conflicts of interest when scientists with an intellectual property interest participate in clinical research in tandem; (3) revisions to the Food and Drug Administration's pre-market approval process for new devices, including a proposal for a mini-investigational device exemption; and (4) the establishment of a public-private partnership to build ethical and sustainable synergies between the scientific community, industry, and government that would foster discovery and innovation.

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. A flexible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100800/-/DC1.

American Society of Clinical Oncology 2009 clinical evidence review on radiofrequency ablation of hepatic metastases from colorectal cancer.

PURPOSE: To review the evidence about the efficacy and utility of radiofrequency ablation (RFA) for hepatic metastases from colorectal cancer (CRHM). METHODS: The American Society of Clinical Oncology (ASCO) convened a panel to conduct and analyze a comprehensive systematic review of the RFA literature from Medline and the Cochrane Collaboration Library. RESULTS: Because data were considered insufficient to form the basis of a practice guideline, ASCO has instead published a clinical evidence review. The evidence is from single-arm, retrospective, and prospective trials. No randomized controlled trials have been included. The following three clinical issues were considered by the panel: the efficacy of surgical hepatic resection versus RFA for resectable tumors; the utility of RFA for unresectable tumors; and RFA approaches (open, laparoscopic, or percutaneous). Evidence suggests that hepatic resection improves overall survival (OS), particularly for patients with resectable tumors without extrahepatic disease. Careful patient and tumor selection is discussed at length in the literature. RFA investigators report a wide variability in the 5-year survival rate (14% to 55%) and local tumor recurrence rate (3.6% to 60%). The reported mortality rate was low (0% to 2%), and the major complications rate was commonly reported to be between 6% and 9%. RFA is currently performed with all three approaches. CONCLUSION: There is a compelling need for more research to determine the efficacy and utility of RFA to increase local recurrence-free, progression-free, and disease-free survival as well as OS for patients with CRHM. Clinical trials have established that hepatic resection can improve OS for patients with resectable CRHM.

The Translational Research Working Group developmental pathway for image-based assessment modalities.

The Image-based assessment modality (IM) pathway refers to one of six Translational Research Working Group (TRWG) pathways that, together, describe the core domains of early translational cancer research. This pathway focuses on approaches that are based on the interaction of energy and living organisms to analyze tissue noninvasively so as to reveal properties relevant to the detection, diagnosis, or prognosis of cancer and precancer; or the response of the cancer to therapy. Examples include, but are not limited to, magnetic resonance imaging and positron emission tomography, as well as contemporary contrast agents designed to probe specific molecular constituents of tumors. The IM pathway is presented as a general outline of the steps required for the effective development, optimization, testing, and validation of image-based modalities. The distinctive features of the IM pathway and issues encountered that represent obstacles to effective and efficient progress through the pathway are discussed. The IM pathway also forms a framework to identify opportunities to address current barriers and is expected to adapt and evolve as the field advances.

The Translational Research Working Group developmental pathway for interventive devices.

The interventive device pathway refers to one of six pathways developed by the Translational Research Working Group (TRWG) that, together, describe the core domains of early translational cancer research. This pathway focuses on the development of devices (as classified by the Food and Drug Administration), designed for local ablation of cancer or precancerous lesions (e.g., radiation therapy, microwave, radiofrequency ablation, and high-intensity focused ultrasound systems). This article describes the distinctive features of the pathway and issues that are encountered in the real-world development of interventive devices for the treatment of cancer. The interventive device pathway is envisioned to be a general guideline of the steps required for effective development, optimization, testing, and validation of developing devices, to be dynamic and adaptable, and to form a framework for discussions focused on improving the efficiency and effectiveness of new device development.

The Translational Research Working Group developmental pathways: introduction and overview.

The Translational Research Working Group (TRWG) was created as a national initiative to evaluate the current status of the National Cancer Institute's investment in translational research and envision its future in an inclusive, representative, and transparent manner. To clarify the challenges facing translational research and facilitate its deliberations, the TRWG conceptualized translational research as a set of developmental processes or pathways focused on various clinical goals. Drawing on the collective knowledge of the TRWG members, six pathways were derived, with two addressing the development of tools designed to characterize an individual's cancer-related health status (biospecimen-based and image-based assessment modalities) and four addressing the development of interventions intended to change cancer-related health status (drugs or biological agents, immune response modifiers, interventive devices, and life-style alterations). The pathways, which share a number of common structural elements, are graphically represented by schematic flowcharts that capture relevant contingencies, decision points, and interdependencies. They are conceived not as comprehensive descriptions of the corresponding real-world processes but as tools designed to serve specific purposes including research program management and research project management, coordination of research efforts, and professional and lay education and communication. Further development of the pathways is encouraged, as is application of the pathway concept to translational research on other diseases.

Workshop on imaging science development for cancer prevention and preemption.

The concept of intraepithelial neoplasm (IEN) as a near-obligate precursor of cancers has generated opportunities to examine drug or device intervention strategies that may reverse or retard the sometimes lengthy process of carcinogenesis. Chemopreventive agents with high therapeutic indices, well-monitored for efficacy and safety, are greatly needed, as is development of less invasive or minimally disruptive visualization and assessment methods to safely screen nominally healthy but at-risk patients, often for extended periods of time and at repeated intervals. Imaging devices, alone or in combination with anticancer drugs, may also provide novel interventions to treat or prevent precancer.

Clinical practice of interventional and cardiovascular radiology: current status, guidelines for resource allocation, future directions.

The practices of interventional radiology and interventional neuroradiology are centered on high-quality direct patient care. These subspecialties have long histories of innovative care that has often revolutionized the treatment of disease and illness. More recently, however, this success has brought about competition from former referring physicians as they have gained access to technology and training that will enable them to obtain credentials for procedures that were formerly in the exclusive domain of interventionalists. Unfortunately, many interventional radiologists find themselves ill-equipped to compete for referrals. This is primarily because many interventional radiology practices lack complete clinical practices, which are critically important in facilitating referrals from the nonspecialists. Accordingly, this document details the critical importance of a complete clinical practice and further outlines the steps required to achieve this goal.

Transportable versus fixed platform CT scanners: comparison of costs.

PURPOSE: To compare the aggregate hospital technical costs of a transportable computed tomographic (CT) scanner used to image patients in an intensive care unit with those of a fixed platform CT scanner in the radiology department. MATERIALS AND METHODS: Direct fixed costs (ie, machine and service contract costs) and direct variable costs (ie, personnel costs) were calculated. Indirect costs, including space costs and departmental overhead, were calculated. Total costs were calculated as the sum of indirect, direct fixed, and direct variable costs. Personnel costs were calculated from time-motion analyses involving 95 patients who underwent brain CT with either a transportable (n = 51) or a fixed platform (n = 44) CT scanner. Costs per examination were calculated by using both low- and high-examination-volume models and compared with use of the Wilcoxon rank sum test. RESULTS: The total cost per examination for the transportable scanner ranged from 108.98 dollars to 167.20 dollars for the high- and low-volume models. Total cost per examination for the fixed platform scanner ranged from 75.24 dollars to 112.39 dollars for the high- and low-volume models. For the transportable scanner, direct fixed, variable, and overhead costs were 87.05 dollars, 70.73 dollars, and 9.42 dollars per examination, respectively, with the low-volume model. The corresponding costs for the fixed platform scanner were 46.66 dollars, 55.69 dollars, and 10.04 dollars, respectively. CONCLUSION: The technical cost of using an in-hospital transportable CT scanner is higher than that of using a fixed platform scanner.