Sample size calculation for clinical trials using magnetic resonance imaging for the quantitative assessment of carotid atherosclerosis.

PURPOSE: To provide sample size calculation for the quantitative assessment of carotid atherosclerotic plaque using non-invasive magnetic resonance imaging in multi-center clinical trials. METHODS. As part of a broader double-blind randomized trial of an experimental pharmaceutical agent, 20 asymptomatic placebo-control subjects were recruited from 5 clinical sites for a multi-center study. Subjects had 4 scans in 13 weeks on GE 1.5 T scanners, using TOF, T1-/PD-/T2- and contrast-enhanced Tl-weighted images. Measurement variability was assessed by comparing quantitative data from the index carotid artery over the four time points. The wall/outer wall (W/OW) ratio was calculated as wall volume divided by outer wall volume. The percent lipid-rich/necrotic core (%LR/NC) and calcification (%Ca) were measured as a proportion of the vessel wall. For %LR/NC and %Ca, only those subjects that exhibited LR/NC or Ca components were used in the analysis. RESULTS: Measurement error was 5.8% for wall volume, 3.2% for W/OW ratio, 11.1% for %LR/NC volume and 18.6% for %Ca volume. Power analysis based on these values shows that a study with 14 participants in each group could detect a 5% change in W/OW ratio, 10% change in wall volume, and 20% change in %LR/NC volume (power = 80%, p < .05). The calculated measurement errors presume any true biological changes were negligible over the 3 months that subjects received placebo. CONCLUSION: In vivo MRI is capable of quantifying plaque volume and plaque composition, such as %lipid-rich/necrotic core and %calcification, in the clinical setting of a multi-center trial with low inter-scan variability. This study provides the basis for sample size calculation of future MRI trials.

Feasibility of in vivo, multicontrast-weighted MR imaging of carotid atherosclerosis for multicenter studies.

PURPOSE: To test the image quality (ImQ) and interscan coverage of MRI for measuring carotid atherosclerosis across multiple centers. MATERIALS AND METHODS: Thirty-nine subjects from five clinical sites (site 1: n=11; site 2: n=16; site 3: n=2; site 4: n=3; site 5: n=7) were imaged on GE 1.5T scanners using a standardized carotid imaging protocol with five weightings (T1, proton density (PD), T2, time-of-flight (TOF), and contrast-enhanced (CE) T1). MR technologists from the five sites received comprehensive protocol training. A maximum coverage of 24 mm (12 slices) was designed for each of four scans (baseline and at four, eight, and 13 weeks). The adequacy of coverage was calculated as the percentage of arteries with at least six slices matched across all four scans. ImQ was evaluated using an established five-point scale for each image. ImQ>or= 3 was considered acceptable for image analysis. RESULTS: Across five sites, the mean ImQ was 3.4-4.2 for T1W, 3.6-4.4 for CE-T1W, 3.4-4.2 for PDW, 3.3-4.2 for T2W, and 3.4-4.0 for TOF. The mean ImQ per site was 3.5-4.2. All sites generated at least six-slice coverage (mean=8.0-9.1) for all index carotid arteries. CONCLUSION: The ImQ and coverage values were comparable among clinical sites using a standardized carotid imaging protocol. With comprehensive protocol training, carotid MRI is technically feasible for use in multicenter studies.

Hemorrhage in the atherosclerotic carotid plaque: a high-resolution MRI study.

BACKGROUND AND PURPOSE: High-resolution, multicontrast magnetic resonance imaging (MRI) has developed into an effective tool for the identification of carotid atherosclerotic plaque components, such as necrotic core, fibrous matrix, and hemorrhage/thrombus. Factors that may lead to plaque instability are lipid content, thin fibrous cap, and intraplaque hemorrhage. Determining the age of intraplaque hemorrhage can give insight to the history and current condition of the biologically active plaque. The aim of this study was to develop criteria for the identification of the stages of intraplaque hemorrhage using high-resolution MRI. METHODS: Twenty-seven patients, scheduled for carotid endarterectomy (CEA), were imaged on a 1.5-T GE SIGNA scanner (sequences: 3-dimensional time of flight, double-inversion recovery, T1-weighted (T1W), PDW and T2W). Two readers, blinded to histology, reviewed MR images and grouped hemorrhage into fresh, recent, and old categories using a modified cerebral hemorrhage criteria. The CEA specimens were serially sectioned and graded as to presence and stage of hemorrhage. RESULTS: Hemorrhage was histologically identified and staged in 145/189 (77%) of carotid artery plaque locations. MRI detected intraplaque hemorrhage with high sensitivity (90%) but moderate specificity (74%). Moderate agreement in classifying stages occurred between MRI and histology (Cohen kappa=0.7, 95% CI: 0.5 to 0.8 for reviewer 1 and 0.4, 95% CI: 0.2 to 0.6 for reviewer 2), with moderate agreement between the 2 MRI readers (kappa=0.4, 95% CI: 0.3 to 0.6). CONCLUSIONS: Multicontrast MRI can detect and classify carotid intraplaque hemorrhage with high sensitivity and moderate specificity.

Comparing image quality of flat-panel chest radiography with storage phosphor radiography and film-screen radiography.

OBJECTIVE: To evaluate image quality of a large-area direct-readout flat-panel detector system in chest radiography, we conducted an observer preference study. A clinical comparative study was conducted of the flat-panel system versus the storage phosphor and standard film-screen systems. MATERIALS AND METHODS: Routine chest radiographs (posteroanterior) of 30 patients that were obtained using flat-panel, storage phosphor, and film screen systems were compared. The visibility of 10 anatomic regions and the overall image quality criteria were rated independently by three radiologists using a 5-point scale. The significance of the differences in diagnostic performance was tested with a Wilcoxon's signed rank test. Dose measurements for the three modalities were performed. RESULTS: The flat-panel radiography system showed an improved visibility in most anatomic structures when compared with a state-of-the-art conventional film-screen system and an equal visibility when compared with a storage phosphor system. The flat-panel system showed the greatest enhancement in the depiction of small detailed structures (p < 0.05) and achieved this with a reduction in overall radiation dose of more than 50%. CONCLUSION: The visibility of anatomic structures provided by this flat-panel detector system is as good as if not better than that provided by conventional or storage phosphor systems while emitting a reduced radiation dose.

Clinical comparative study with a large-area amorphous silicon flat-panel detector: image quality and visibility of anatomic structures on chest radiography.

OBJECTIVE: The objective of this study was to compare clinical chest radiographs of a large-area, flat-panel digital radiography system and a conventional film-screen radiography system. The comparison was based on an observer preference study of image quality and visibility of anatomic structures. MATERIALS AND METHODS: Routine follow-up chest radiographs were obtained from 100 consecutive oncology patients using a large-area, amorphous silicon flat-panel detector digital radiography system (dose equivalent to a 400-speed film system). Hard-copy images were compared with previous examinations of the same individuals taken on a conventional film-screen system (200-speed). Patients were excluded if changes in the chest anatomy were detected or if the time interval between the examinations exceeded 1 year. Observer preference was evaluated for the image quality and the visibility of 15 anatomic structures using a five-point scale. RESULTS: Dose measurements with a chest phantom showed a dose reduction of approximately 50% with the digital radiography system compared with the film-screen radiography system. The image quality and the visibility of all but one anatomic structure of the images obtained with the digital flat-panel detector system were rated significantly superior (p < or = 0.0003) to those obtained with the conventional film-screen radiography system. CONCLUSION: The image quality and visibility of anatomic structures on the images obtained by the flat-panel detector system were perceived as equal or superior to the images from conventional film-screen chest radiography. This was true even though the radiation dose was reduced approximately 50% with the digital flat-panel detector system.