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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., (RSNA, 2011)

Purpose: To determine effects of lesion type (calcification vs mass) and image processing on radiologist's performance for area under the receiver operating characteristic curve (AUC), sensitivity, and specificity for detection of masses and calcifications with digital mammography in women with mammographically dense breasts., Materials and Methods: This study included 201 women who underwent digital mammography at seven U.S. and Canadian medical centers. Three image-processing algorithms were applied to the digital images, which were acquired with Fischer, General Electric, and Lorad digital mammography units. Eighteen readers participated in the reader study (six readers per algorithm). Baseline values for reader performance with screen-film mammograms were obtained through the additional interpretation of 179 screen-film mammograms. A repeated-measures analysis of covariance allowing unequal slopes was used in each of the nine analyses (AUC, sensitivity, and specificity for each of three machines). Bonferroni correction was used., Results: Although lesion type did not affect the AUC or sensitivity for Fischer digital images, it did affect specificity (P =.0004). For the General Electric digital images, AUC, sensitivity, and specificity were not affected by lesion type. For Lorad digital images, the results strongly suggested that lesion type affected AUC and sensitivity (P <.0001). None of the three image-processing methods tested affected the AUC, sensitivity, or specificity for the Fischer, General Electric, or Lorad digital images., Conclusion: Findings in this study indicate that radiologist's interpretation accuracy in interpreting digital mammograms depends on lesion type. Interpretation accuracy was not influenced by the image-processing method.

Purpose: To compare the speed and accuracy of the interpretations of digital mammograms by radiologists by using printed-film versus soft-copy display., Materials and Methods: After being trained in interpretation of digital mammograms, eight radiologists interpreted 63 digital mammograms, all with old studies for comparison. All studies were interpreted by all readers in soft-copy and printed-film display, with interpretations of images in the same cases at least 1 month apart. Mammograms were interpreted in cases that included six biopsy-proved cancers and 20 biopsy-proved benign lesions, 20 cases of probably benign findings in patients who underwent 6-month follow-up, and 17 cases without apparent findings. Area under the receiver operating characteristic curve (A(z)), sensitivity, and specificity were calculated for soft-copy and printed-film display., Results: There was no significant difference in the speed of interpretation, but interpretations with soft-copy display were slightly faster. The differences in A(z), sensitivity, and specificity were not significantly different; A(z) and sensitivity were slightly better for interpretations with printed film, and specificity was slightly better for interpretations with soft copy., Conclusion: Interpretation with soft-copy display is likely to be useful with digital mammography and is unlikely to significantly change accuracy or speed., (Copyright RSNA, 2002)

Purpose: To determine the preferences of radiologists among eight different image processing algorithms applied to digital mammograms obtained for screening and diagnostic imaging tasks., Materials and Methods: Twenty-eight images representing histologically proved masses or calcifications were obtained by using three clinically available digital mammographic units. Images were processed and printed on film by using manual intensity windowing, histogram-based intensity windowing, mixture model intensity windowing, peripheral equalization, multiscale image contrast amplification (MUSICA), contrast-limited adaptive histogram equalization, Trex processing, and unsharp masking. Twelve radiologists compared the processed digital images with screen-film mammograms obtained in the same patient for breast cancer screening and breast lesion diagnosis., Results: For the screening task, screen-film mammograms were preferred to all digital presentations, but the acceptability of images processed with Trex and MUSICA algorithms were not significantly different. All printed digital images were preferred to screen-film radiographs in the diagnosis of masses; mammograms processed with unsharp masking were significantly preferred. For the diagnosis of calcifications, no processed digital mammogram was preferred to screen-film mammograms., Conclusion: When digital mammograms were preferred to screen-film mammograms, radiologists selected different digital processing algorithms for each of three mammographic reading tasks and for different lesion types. Soft-copy display will eventually allow radiologists to select among these options more easily.

Purpose: To determine the effect of glucagon and orally administered contrast material on hepatic enhancement and metastatic lesion conspicuity on computed tomographic (CT) scans., Materials and Methods: Nine patients with a history of hepatic metastasis underwent two CT examinations with intravenously administered contrast material. Each patient was given orally administered CT contrast material for the first examination. No oral contrast material was given in the second examination. Five patients underwent the initial CT with intravenous administration of 1 mg of glucagon; the second examination was performed without glucagon. Four patients were administered glucagon before the second examination, but no glucagon was administered before the first. Attenuation in the liver, portal vein, and aorta was measured by observers blinded to whether the patient had been given glucagon. Lesion conspicuity was rated on a continuous scale., Results: Greater mean hepatic enhancement was noted on scans of patients in whom oral contrast material was administered (mean, 52 HU) versus those in whom no oral contrast material was administered (mean, 47 HU; P = .019). Glucagon was not associated with greater hepatic enhancement. Neither oral contrast material nor glucagon had a significant effect on lesion conspicuity., Conclusion: Oral CT contrast material is associated with a small increase in hepatic enhancement that does not appear to be clinically important. Glucagon does not appear to affect hepatic enhancement or lesion conspicuity in humans.

Purpose: Interpretation time of serial staging chest CT cases, which each contained current and previous examinations, with a simple prototype workstation called filmstack was experimentally compared with interpretation time with a film alternator., Materials and Methods: The filmstack displayed a "stack" of sections for each examination; user controls allowed rapid selection of preset attenuation windows and both synchronized and unsynchronized scrolling. Eight radiologists were timed as they used the filmstack and the film alternator to interpret four ergonomically complex serial CT cases., Results: All reports dictated on the basis of findings with filmstack and film were of acceptable clinical accuracy. The time to examine a case with filmstack was significantly faster than the time with film, including the time to load and unload the alternator (99% confidence [P = .01]). There was no statistically significant difference in interpretation time between filmstack and prehung film., Conclusion: Use of a low-cost stacked CT workstation with a single 1,024 x 1,024 monitor is an effective means of interpreting cases that require comparison of multiple CT examinations.

A prototype single-screen workstation with a 2,048 x 2,560-pixel high-brightness monitor, 0.11-second image display time, and simple ergonomic design was compared to a conventional horizontal film alternator in diagnostic interpretation of chest computed tomography (CT) studies. Four radiologists used either the workstation or film alternator in interpretation of studies obtained in 10 patients. A counterbalanced within-subject repeated measures experimental design was used. Response times were analyzed for both methods of interpretation. Grades of excellent, acceptable, and unacceptable were assigned by a blinded "grader" to reports of the radiologists. The average time needed for an interpretation at the workstation was 5.65 minutes. No interpretations were graded unacceptable. Retrospective power analysis showed that 16 observers rather than four would have been required to show that use of the workstation was faster than the alternator. With this 95% confidence interval, the workstation interpretation time is clinically equivalent to that with the alternator. These data show that this type of workstation has practical application in interpretation of CT, magnetic resonance imaging, and ultrasound studies.