Biomedical subjects

James S Babb

Publications and source records attributed to James S Babb.

At least 19 recordsLinked to original sources

PubMed2007

Multi-detector row CT attenuation measurements: assessment of intra- and interscanner variability with an anthropomorphic body CT phantom.

PURPOSE: To determine the dependence of absolute computed tomographic (CT) attenuation values on multi-detector row CT scanner type, convolution kernel, and tube current by using an anthropomorphic phantom. MATERIALS AND METHODS: A customized phantom was designed with tissue-equivalent materials to simulate contrast material-enhanced liver, spleen, pancreas, aorta, kidney, 0- and 50-HU cylindric renal cysts, muscle, and fat. The phantom was scanned with five multi-detector row CT scanners (LightSpeed QXi, GE Healthcare, Milwaukee, Wis; MX8000, Philips Medical Systems, Best, the Netherlands; and Volume Zoom, Sensation 16 and Sensation 64, Siemens Medical Solutions, Forchheim, Germany) on five separate occasions with 120 kVp, low and high tube current settings, 3.00-3.75-mm section thickness, 50% overlap, and standard and high-spatial-resolution kernels. Standardized regions of interest (ROIs) were used to obtain 3510 attenuation measurements. Attenuation dependence on scanner, kernel, and tube current was evaluated by using F tests derived with mixed-model regression. Within the mixed-model framework, the Tukey honestly significant difference procedure and a Bonferroni multiple comparison correction were used to assess differences among imaging regimens and tube current settings, respectively, in terms of tissue attenuation and ROI standard deviation. RESULTS: Tube current had no significant effect (P>.4) on observed tissue attenuation. Significant (P<.0001) differences were observed between imaging regimens with respect to mean attenuation for each tissue type. Convolution kernel modification had an inconsistent effect on tissue attenuation, depending on the scanner. All multi-detector row CT scanners displayed intrascanner variability in tissue attenuation (minimum range: 8.4 HU for fat tissue with the Sensation 16; maximum range: 63.4 HU for liver tissue with the Sensation 64). The scanners behaved differently at the lower range of the CT number scale, where 0-HU cyst attenuation ranged from -15.7 to 23.9 HU and one vendor's equipment showed significantly lower mean attenuation values. CONCLUSION: CT attenuation values vary significantly between different manufacturers' multi-detector row CT scanners, among different generations of multi-detector row CT scanning equipment, and with individual combinations of scanner and convolution kernel. SUPPLEMENTAL MATERIAL: http://radiology.rsnajnls.org/cgi/content/full/242/1/109/DC1

Anthropometry↗

PubMed2006

Pattern of hemodynamic impairment in multiple sclerosis: dynamic susceptibility contrast perfusion MR imaging at 3.0 T.

This study aimed to determine regional pattern of tissue perfusion in the normal-appearing white matter (NAWM) of patients with primary-progressive (PP), relapsing-remitting (RR) multiple sclerosis (MS) and healthy controls, and to investigate the association between perfusion abnormalities and clinical disability. Using dynamic susceptibility contrast (DSC) perfusion MRI at 3 T, we studied 22 patients with clinically definite MS, 11 with PP-MS and 11 with RR-MS and 11 age- and gender-matched healthy volunteers. The MRI protocol included axial dual-echo, dynamic susceptibility contrast enhanced (DSC) T2*-weighted and post-contrast T1-weighted images. Absolute cerebral blood flow (CBF), cerebral blood volume (CBV) and mean transit time (MTT) were measured in the periventricular, frontal, occipital NAWM and in the splenium of the corpus callosum. Compared to controls, CBF and CBV were significantly lower in all NAWM regions in both PP-MS patients (p values from <0.0001 to 0.001) and RR-MS (p values from <0.0001 to 0.020). Compared to RR-MS, PP-MS patients showed significantly lower CBF in the periventricular NAWM (p=0.002) and lower CBV in the periventricular and frontal NAWM (p values: 0.0029 and 0.022). EDSS was significantly correlated with the periventricular CBF (r=-0.48, p=0.0016) and with the periventricular and frontal CBV (r=-0.42, p=0.015; r=-0.35, p=0.038, respectively). This study suggests that the hemodynamic abnormalities of NAWM have clinical relevance in patients with MS. DSC perfusion MRI might provide a relevant objective measure of disease activity and treatment efficacy.

Adult↗

PubMed2006

Risk for unplanned hospital readmission of patients with cancer: results of a retrospective medical record review.

PURPOSE/OBJECTIVES: To identify potential factors that place patients with cancer at risk for unplanned readmissions after discharge from the hospital. DESIGN: Retrospective, descriptive, medical record review. SETTING: A National Cancer Institute-designated comprehensive cancer center in an urban area of the Northeastern United States. SAMPLE: 78 patients were selected from those readmitted within seven days of discharge. For each readmission case, a nonreadmitted patient was randomly selected and matched on discharge date and reason for prior admission. The age range was 22-87 years, men and women were equally represented, and 88% were Caucasian. METHODS: The Readmission Criteria Record was developed to collect data from medical records about factors associated with readmission, including demographics, severity of illness, support at home, symptoms, and comorbidities. MAIN RESEARCH VARIABLES: Criteria associated with readmission risk. FINDINGS: Patients who had gastrointestinal cancer, nausea within 24 hours of discharge, financial and insurance concerns, or caregiver difficulty or those who lived alone were more likely to be readmitted within seven days of discharge. Patients were more likely to be readmitted on Friday than any other day. Among readmitted patients, 48% were readmitted within one to two days postdischarge. CONCLUSIONS: Knowledge of factors that may place patients with cancer at an increased risk for readmission and subsequent implementation of appropriate interventions during hospitalization may help to decrease risk of readmission. IMPLICATIONS FOR NURSING: The factors identified provide a basis for assessment, planning, interventions, and follow-up of patients to help reduce the risk of readmission and, thus, poor outcomes.

Adult↗

PubMed2006

Shoulder impingement: objective 3D shape analysis of acromial morphologic features.

PURPOSE: To retrospectively and quantitatively analyze the acromial undersurface in three dimensions and to determine its association with impingement syndrome and rotator cuff tears. MATERIALS AND METHODS: Institutional review board approval was received with exemption of informed consent for this retrospective HIPAA-compliant study. Magnetic resonance images were evaluated in 84 patients (63 males, 21 females; mean age, 42.6 years; age range, 15-74 years). On the basis of surgical results, patients were separated into three groups: those without shoulder impingement or rotator cuff tears (31 patients), those with shoulder impingement (22 patients), and those with rotator cuff tears (31 patients). To quantitate the acromial undersurface, the structure was manually plotted, and a mathematic model was created by using splines. The undersurface was divided into a 20 x 20 grid. For each patient, a shape index (SI) data set and local undersurface angulation (LUA) data set were determined. Regression analyses were used to identify differences between groups, and prediction models were constructed on the basis of correspondent areas. RESULTS: Analysis of both data sets yielded no apparent progression between groups and demonstrated a lack of similarity between the impingement and rotator cuff tear groups. Discrimination between groups could be demonstrated by dividing the lateral portion of the acromial undersurface into contiguous blocks. The highest overall diagnostic accuracy of our prediction models was 58.3% (49 of 84) by using 10 blocks of the SI data set and 73.8% (62 of 84) by using five blocks of the LUA data set. CONCLUSION: Three-dimensional modeling yields objective data about the acromial undersurface. On the basis of this method, osseous impingement by the acromion is not a primary cause of shoulder impingement syndrome or rotator cuff tears.

Acromion↗

PubMed2006

Sclerosis of the pterygoid process in untreated patients with nasopharyngeal carcinoma.

PURPOSE: To retrospectively evaluate the prevalence of pterygoid process sclerosis in patients with untreated nasopharyngeal carcinoma. MATERIALS AND METHODS: This retrospective HIPAA-compliant study was performed after the institutional review board deemed it to be exempt from review and patient informed consent. Contrast material-enhanced computed tomographic (CT) scans of the neck obtained in 31 patients (22 men, nine women; mean age, 42 years; age range, 27-68 years) with untreated nasopharyngeal carcinoma and in 31 control subjects (17 men, 14 women; mean age, 43 years; age range, 19-62 years) were evaluated independently by two neuroradiologists. The presence of sclerosis of the pterygoid process-defined as increased attenuation in the medullary cavity and/or thickening of the cortical bone-was assessed. Other findings noted included pterygoid process erosion, enhancing tumor adjacent to the pterygoid process, and CT evidence of parapharyngeal extension of the tumor. The data were evaluated by using generalized estimating equations based on a binary logistic regression model. RESULTS: The prevalence of pterygoid process sclerosis averaged for the two readers was 60% (37 of 62 subjects) among the patients with nasopharyngeal carcinoma but only 3% (two of 62 subjects) among the control subjects, indicating a highly significantly increased prevalence (P < .001) of this finding in the patients with nasopharyngeal carcinoma. The overall prevalences of pterygoid process erosion, parapharyngeal extension of tumor, and enhancing tumor adjacent to the pterygoid process were 27% (17 of 62 subjects), 47% (29 of 62 subjects), and 77% (48 of 62 subjects), respectively. Pterygoid process sclerosis was the sole skull base abnormality in 36% (11 of 31) of the patients with nasopharyngeal carcinoma. CONCLUSION: Sclerosis of the pterygoid process, which was present in about half of the patients with untreated nasopharyngeal carcinoma, may reflect tumor proximity to or tumor invasion of the pterygoid process.

Adult↗

PubMed2006

Low-grade gliomas: dynamic susceptibility-weighted contrast-enhanced perfusion MR imaging--prediction of patient clinical response.

PURPOSE: To determine retrospectively whether relative cerebral blood volume (CBV) measurements can be used to predict clinical response in patients with low-grade gliomas. MATERIALS AND METHODS: Approval for this retrospective HIPAA-compliant study was obtained from the Institutional Board of Research Associates, with waiver of informed consent. Thirty-five patients (23 male and 12 female patients; median age, 39 years; range, 4-80 years) with histologically diagnosed low-grade gliomas (21 low-grade astrocytomas and 14 low-grade oligodendrogliomas and low-grade mixed oligoastrocytomas) were examined with dynamic susceptibility-weighted contrast material-enhanced perfusion magnetic resonance (MR) imaging. Wilcoxon tests were used to compare patients in different response categories (complete response, stable, progressive, death) with respect to baseline relative CBV. Kaplan-Meier survival curves, log-rank tests, and Weibull survival models were used to characterize and evaluate the association of baseline relative CBV with time to progression. Tumor volumes and relative CBV measurements were obtained at initial examination and follow-up. RESULTS: Lesions with relative CBV less than 1.75 had a median time to progression of 4620 days +/- 433 (standard deviation), and lesions with relative CBV more than 1.75 had a median time to progression of 245 days +/- 62. Patients who had an adverse event (either death or progression) had significantly higher (P = .003) relative CBV than did patients without adverse events (either complete response or stable disease). Lesions with low baseline relative CBV had stable tumor volumes at follow-up over time, whereas those with high baseline relative CBV (>1.75) had progressively increasing tumor volumes over time. CONCLUSION: Dynamic susceptibility-weighted contrast-enhanced perfusion MR imaging can help to identify low-grade gliomas that will progress rapidly and a subset of low-grade gliomas that have a propensity for malignant transformation.

Adolescent↗

PubMed2006

Comparing real-world advantages for the clinical neuroradiologist between a high field (3 T), a phased array (1.5 T) vs. a single-channel 1.5-T MR system.

PURPOSE: To evaluate signal-to-noise ratio (SNR) and neuroradiologists' subjective assessments of image quality in 3-Tesla (3-T) or phased-array MR systems that are now available for clinical neuroimaging. MATERIALS AND METHODS: Brain MR images of six normal volunteers were obtained on each of three scanners: a 1.5-T single-channel system, a 12-channel, phased-array system, and a 3-T single-channel system. Additionally, clinically optimized images acquired from 28 patients who underwent imaging in more than one of these systems were analyzed. SNRs were measured and image quality and artifact conspicuity were graded by two blinded readers. RESULTS: The phased-array system produced higher SNR than either the 1.5-T or the 3-T single-channel systems, and in no instance was it outperformed. Both blinded readers judged the phased-array images to be of higher quality than those produced by the single-channel systems, with significantly less artifact. The 3-T magnet produced images with high SNR, but with increased artifact conspicuity. The phased-array system markedly decreased acquisition times without introduction of artifacts. CONCLUSION: Both quantitatively and qualitatively, the phased-array system provided image quality superior to that of the 1.5-T and 3-T single-channel systems.

Adult↗

PubMed2006

Clinical significance of dilated Virchow-Robin spaces in mild traumatic brain injury.

PRIMARY OBJECTIVE: To investigate the relationship between the number of dilated Virchow-Robin spaces (VRS) and neurocognitive findings in patients with traumatic brain injury (TBI). RESEARCH DESIGN: Thirty-eight patients with TBI and 21 controls were studied. METHODS AND PROCEDURES: Fifteen patients underwent MRI within a mean interval of 5.4 (range 1-12) days from the brain injury and 23 after an average period of 5.5 (range 0.2-31) years. All subjects were examined with a battery of 13 neuropsychological tests (NP). MAIN OUTCOMES AND RESULTS: The average number of VRS was significantly higher in patients than in controls. There were no significant differences between patients and controls in terms of NP tests. The number of VRS showed a significant inverse correlation with processing speed and a positive correlation with visual perceptual of attention only in patients studied within a short delay of trauma. CONCLUSIONS: VRS are not directly associated to neurocognitive findings, suggesting that they may represent a result of the shear-strain injury.

Adolescent↗

PubMed2006

Effect of blood vessels on measurement of nodule volume in a chest phantom.

PURPOSE: To identify, by using a chest phantom, whether vessels that contact lung nodules measuring less than 5 mm in diameter will affect nodule volume assessment. MATERIALS AND METHODS: Forty synthetic nodules (20 with ground-glass attenuation and 20 with solid attenuation) that measured less than 5 mm in diameter were placed into a chest phantom either adjacent to (n = 30) or isolated from (n = 10) synthetic vessels. Nodules were imaged by using low-dose (20 mAs) and diagnostic (120 mAs) multi-detector row computed tomography (CT). Nodules that were known to lie in direct contact with vessels were confirmed by visual inspection. Nontargeted 1.25 x 1.00-mm sections were analyzed with a three-dimensional computer-assisted method for measuring nodule volume. A mixed-model analysis of variance was used to examine the influence of several factors (eg, the presence of adjacent vessels; tube current-time product; and nodule attenuation, diameter, and location) on measurement error. RESULTS: The mean absolute error (MAE) for all nodules adjacent to vessels was 2.3 mm(3), which was higher than the MAE for isolated nodules (1.9 mm(3)) (P < .001). This difference proved significant only for diagnostic CT (2.2 mm(3) for nodules adjacent to vessels vs 1.3 mm(3) for nodules isolated from vessels) (P < .05). A larger MAE was noted for nodules with ground-glass attenuation (2.3 mm(3)) versus those with solid attenuation (2.0 mm(3)), for increasing nodule volume (1.66 mm(3) for nodules smaller than 20 mm(3) vs 2.83 mm(3) for nodules larger than 40 mm(3)), and for posterior nodule location (P < .05). CONCLUSION: The presence of a vessel led to a small yet significant increase in volume error on diagnostic-quality images. This represents less than one-third of the overall error, even for nodules larger than 40 mm(3) or approximately 4 mm in diameter. This increase, however, may be more important for smaller nodules with errors of less than 3 mm(3).

Diagnostic Errors↗

PubMed2006

Hepatocellular carcinoma in the cirrhotic liver: gadolinium-enhanced 3D T1-weighted MR imaging as a stand-alone sequence for diagnosis.

PURPOSE: To retrospectively assess the usefulness of contrast material-enhanced T1-weighted magnetic resonance (MR) imaging alone and with T2-weighted MR imaging in the diagnosis of hepatocellular carcinoma (HCC). MATERIALS AND METHODS: A waiver of informed consent and institutional review board approval for this retrospective study were granted. The study was HIPAA compliant. Twenty-eight men (mean age, 49 years; range, 23-70 years) and 10 women (mean age, 53 years; range, 42-72 years) with cirrhosis underwent T2-weighted and contrast-enhanced T1-weighted MR imaging at 1.5 T within 90 days of liver transplantation. Three readers reviewed the T1-weighted images alone and then the T2-weighted and T1-weighted images together. Lesion detection, characterization, and reader confidence levels were recorded. RESULTS: At liver explantation, 57 lesions were present in 18 patients: 19 HCCs, 33 dysplastic nodules, and five cysts. Contrast-enhanced T1-weighted imaging depicted 13 of 19 HCCs with an overall sensitivity of 68.4% (13 of 19) and specificity of 65.7% (23 of 35). The sensitivity and specificity for detection of dysplastic nodules (sensitivity, 9%; specificity, 68.4%) and HCCs (sensitivity, 68.4%; specificity, 65.7%) were nearly identical for T1-weighted images read alone or read with T2-weighted images. The only difference was the specificity for T1-weighted images read alone (65.7%) and read with T2-weighted images (62.9%). The addition of T2-weighted images altered the diagnosis in one of 90 (1.1%) cases and provided an increase in diagnostic confidence in four of 258 (1.6%) cases for independent readers and three of 90 (3.3%) cases at consensus reading. CONCLUSION: Contrast-enhanced T1-weighted imaging can be used as a stand-alone sequence for the diagnosis of HCC in patients with cirrhosis prior to liver transplantation.

Adult↗

PubMed2006

Perfusion magnetic resonance imaging predicts patient outcome as an adjunct to histopathology: a second reference standard in the surgical and nonsurgical treatment of low-grade gliomas.

OBJECTIVE: To determine whether relative cerebral blood volume (rCBV) can predict patient outcome, specifically tumor progression, in low-grade gliomas (LGGs) and thus provide a second reference standard in the surgical and postsurgical management of LGGs. METHODS: Thirty-five patients with histologically diagnosed LGGs (21 low-grade astrocytomas and 14 low-grade oligodendrogliomas and low-grade mixed oligoastrocytomas) were studied with dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging. Wilcoxon tests were used to compare patients in different response categories (complete response, stable, progressive, death) with respect to baseline rCBV. Log-rank tests were used to evaluate the association of rCBV with survival and time to progression. Kaplan-Meier time-to-progression curves were generated. Tumor volumes and CBV measurements were obtained at the initial examination and again at follow-up to determine the association of rCBV with tumor volume progression. RESULTS: Wilcoxon tests showed patients manifesting an adverse event (either death or progression) had significantly higher rCBV (P = 0.003) than did patients without adverse events (complete response or stable disease). Log-rank tests showed that rCBV exhibited a significant negative association with disease-free survival (P = 0.0015), such that low rCBV values were associated with longer time to progression. Kaplan-Meier curves demonstrated that lesions with rCBV less than 1.75 (n = 16) had a median time to progression of 4620 +/- 433 days, and lesions with rCBV more than 1.75 (n = 19) had a median time to progression of 245 +/- 62 days (P < 0.005). Lesions with low baseline rCBV (< 1.75) demonstrated stable tumor volumes when followed up over time, and lesions with high baseline rCBV (> 1.75) demonstrated progressively increasing tumor volumes over time. CONCLUSION: Dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging may be used to identify LGGs that are either high-grade gliomas, misdiagnosed because of sampling error at pathological examination or that have undergone angiogenesis in the progression toward malignant transformation. This suggests that rCBV measurements may be used as a second reference standard to determine the surgical management/risk-benefit equation and postsurgical adjuvant therapy for LGGs.

Adolescent↗

PubMed2006

Isotropic 3D T2-weighted MR cholangiopancreatography with parallel imaging: feasibility study.

OBJECTIVE: The aim of this study was to compare the quality of images obtained with fast 3D T2-weighted turbo spin-echo (TSE) MR cholangiopancreatography (MRCP) sequences and 1-mm isotropic voxels with the quality of conventional 2D MRCP images. SUBJECTS AND METHODS: Thirty consecutively registered patients (14 women, 16 men; average age, 60.2 years; age range, 32-87 years) underwent imaging at 1.5 T with a 6-element body array coil. All imaging was performed with three MRCP techniques: free-breathing 3D T2-weighted TSE (TR/TE, 1,300/680; flip angle, 180 degrees; field of view, 250-300 mm; matrix size, 256 x 256; slice thickness, 1 mm; parallel acquisition technique factor, 2); breath-hold 3D T2-weighted TSE (same parameters as the free-breathing 3D technique); breath-hold coronal and oblique coronal thick-slab 2D TSE without parallel acquisition technique (2,800/1,100; flip angle, 150-180 degrees). Quantitative measures of image signal and contrast were evaluated by analysis of variance and paired Student's t tests. A 5-point scale (1, nondiagnostic, to 5, high diagnostic confidence) was used to compare the 3D and 2D data sets for image quality and definition of biliary and pancreatic ductal anatomic features. Friedman's nonparametric and Wilcoxon's rank sum tests were performed for statistical analysis of the qualitative assessments. RESULTS: Quantitative results showed free-breathing and breath-hold 3D TSE images had significantly higher relative signal intensity and contrast than 2D TSE images (p < 0.0001). The qualitative findings showed that both free-breathing and breath-hold 3D TSE techniques gave better delineation of biliary anatomy (p < 0.0001) than the 2D technique. The overall quality of 3D images was better than that of 2D images, and 3D imaging was better at depicting pancreatic ducts, although the difference did not reach statistical significance. CONCLUSION: Three-dimensional volumetric MRCP images are of superior quality and give better delineation of pancreaticobiliary anatomy than conventional 2D images and have the added advantage of multiplanar and postprocessing capabilities.

Adult↗

PubMed2005

Evaluation of bowel distention and bowel wall appearance by using neutral oral contrast agent for multi-detector row CT.

PURPOSE: To prospectively evaluate the performance of an orally administered 0.1% barium suspension, Volumen, as a bowel-marking agent for multi-detector row computed tomography (CT). MATERIALS AND METHODS: This HIPAA-compliant study was approved by the Institutional Review Board and conformed to the institutional standards for research funded by a commercial sponsor. A total of 60 patients (33 women, 27 men; average age, 58.2 years) who were referred for multi-detector row CT of the pancreas were randomized into two groups. Prior to examination, group 1 consumed 1200 mL of Volumen over a 30-minute period and group 2 consumed 1200 mL of a solution containing three parts water and one part methylcellulose over a 30-minute period. Results were independently reviewed by two radiologists who were unaware of the contrast agent used. The degree of distention and the visualization of mural detail were qualitatively scored on a five-point scale. Differences were evaluated by using the Mann-Whitney test at a confidence level of 95%. RESULTS: There was significantly better distention in the stomach (P = .013), duodenum (P = .006), jejunum (P = .029), and ileum (P = .014) [corrected] in group 1 compared with group 2. Significant distention was also evident by comparing the products of the widest cross-sectional diameters in duodenum (P = .143), jejunum (P < .001), and ileum (P < .001). Group 1 also demonstrated significantly better visualization of mural features in the duodenum (P = .003), jejunum (P = .024), and ileum (P = .01) and a trend toward better visualization of mural features in the stomach (P = .092). CONCLUSION: Oral administration of Volumen provided excellent distention and excellent visualization of mural features in the gastrointestinal tract.

Administration, Oral↗

PubMed2005

Effect of CT image compression on computer-assisted lung nodule volume measurement.

PURPOSE: To evaluate the effect of two-dimensional wavelet-based computed tomographic (CT) image compression according to the Joint Photographic Experts Group (JPEG) 2000 standard on computer-assisted assessment of nodule volume. MATERIALS AND METHODS: This HIPAA-compliant study was approved by the research board at the authors' institution; patients' informed consent was not required. Fifty-one nodules in 23 patients (seven men, 16 women; mean age, 59 years; age range, 39-75 years) were selected on low-dose CT scans that were compressed to levels of 10:1, 20:1, 30:1, and 40:1 by using a two-dimensional JPEG 2000 wavelet-based image compression method. Nodules were classified according to size (< or = 5 mm or > 5 mm in diameter), location (central, peripheral, or abutting pleura or fissures), and attenuation (solid, calcified, or subsolid). Regions of interest were placed on the original images and transposed onto compressed images. Nodule volumes on original (noncompressed) and compressed images were measured by using a computer-assisted method. A mixed-model analysis of variance was conducted for statistical evaluation. RESULTS: Nodule volumes averaged 388.1 mm3 (range, 34-3474 mm3). There were three calcified, 33 solid noncalcified, and 15 subsolid nodules (13 with ground-glass attenuation). Average volume decreased with increasing compression level, to 383 mm3 (10:1), 370 mm3 (20:1), 360 mm3 (30:1), and 354 mm3 (40:1). No significant difference was identified between measurements obtained on original images and those compressed to a level of 10:1. Significant differences were noted, however, between original images and those compressed to a level of 20:1 or greater (P < .05). Compression level significantly interacted with nodule size, location, and attenuation (P < .001). The effect of compression was greater for nodules with ground-glass attenuation than for those with higher attenuation values. The difference in mean volumes between original images and those compressed to a level of 20:1 was 34.9 mm3 for nodules with ground-glass attenuation, compared with 8.3 mm3 for higher-attenuation nodules, a 4.2-fold difference. CONCLUSION: Nodule volumes measured on images compressed to a level of 20:1 differed significantly from those measured on noncompressed images, especially for nodules with ground-glass attenuation. This difference could affect the assessment of nodule change in size as measured with computer-assisted methods.

Adult↗

PubMed2005

New paradigm in dose-finding trials: patient-specific dosing and beyond phase I.

We propose a new paradigm for the clinical evaluation of new cancer therapies. It entails adjusting the search for the optimal dose on the basis of measurable patient characteristics that may be predictive of adverse responses to treatment, and extending this search beyond phase I and into phases II and III. We provide examples of (a) how the fine-tuning of dose may involve utilization of patient-specific attributes to obtain a personalized treatment regimen, and (b) how novel methods for phase I design can be used to update the working dose for the conduct of phase II and III cancer clinical trials. These examples should be interpreted as an enticement for the development of new methods to implement the proposed new paradigm.

Antineoplastic Agents↗

PubMed2005

Flexible Bayesian methods for cancer phase I clinical trials. Dose escalation with overdose control.

We examine a large class of prior distributions to model the dose-response relationship in cancer phase I clinical trials. We parameterize the dose-toxicity model in terms of the maximum tolerated dose (MTD) gamma and the probability of dose limiting toxicity (DLT) at the initial dose rho(0). The MTD is estimated using the EWOC (escalation with overdose control) method of Babb et al. We show through simulations that a candidate joint prior for (rho0,gamma) with negative a priori correlation structure results in a safer trial than the one that assumes independent priors for these two parameters while keeping the efficiency of the estimate of the MTD essentially unchanged.

Antimetabolites, Antineoplastic↗

PubMed2005

Subclavian steal syndrome: diagnosis with perfusion metrics from contrast-enhanced MR angiographic bolus-timing examination--initial experience.

PURPOSE: To retrospectively determine whether differential temporal changes in signal intensity of the vertebral arteries, measured at a bolus-timing examination with a test dose of a gadolinium-based contrast agent, are present in patients with subclavian steal syndrome. MATERIALS AND METHODS: Institutional review board exemption was obtained, and informed consent was not required for this retrospective study. The study complied with the Health Insurance Portability and Accountability Act. Twenty-five patients with known or clinically suspected atherosclerotic disease of the aortic arch and branch vessels underwent breath-hold contrast material-enhanced magnetic resonance (MR) angiography with circulation time derived from a timing examination by using a test bolus of a gadolinium-based contrast agent. Eight patients (three men and five women aged 54-80 years; mean, 70 years) had subclavian stenosis or occlusion with retrograde vertebral artery flow confirmed with time-of-flight MR angiography, nine patients (eight men and one woman aged 31-91 years; mean, 70 years) had mild to severe ostial stenosis of a single vertebral artery, and eight patients (including four men and four women aged 53-86 years; mean, 73 years) had normal vertebral arteries. The difference in time to peak signal intensity between the right and left vertebral arteries was compared among the three groups by using Fisher exact and Cochran-Mantel-Haenszel tests. RESULTS: The delay in peak enhancement in the ipsilateral vertebral artery ranged from 2 to 4 seconds (mean, 2.5 seconds) in all eight patients with subclavian steal syndrome. In eight of nine patients with ostial vertebral artery stenosis and eight controls, both vertebral arteries filled simultaneously. The presence of unilateral delayed vertebral artery enhancement was significantly associated with retrograde flow in patients with subclavian steal syndrome, compared with patients with normal flow (P < .01) and those with ostial vertebral artery stenosis (P < .01). CONCLUSION: A bolus-timing examination performed with a test bolus of the gadolinium-based contrast agent via the neck vessels that demonstrates at least a 2-second delay in peak contrast enhancement in the right or left vertebral arteries may, in the appropriate clinical setting, indicate subclavian steal syndrome.

Aged↗

PubMed2005

Immune-mediated inhibition of metastases after treatment with local radiation and CTLA-4 blockade in a mouse model of breast cancer.

PURPOSE: Ionizing radiation therapy (RT) is an important component in the management of breast cancer. Although the primary tumor can be successfully treated by surgery and RT, metastatic breast cancer remains a therapeutic challenge. Here we tested the hypothesis that the combination of RT to the primary tumor with CTLA-4 blockade can elicit antitumor immunity inhibiting the metastases. EXPERIMENTAL DESIGN: The poorly immunogenic metastatic mouse mammary carcinoma 4T1 was used as a model. Mice were injected s.c. with 4T1 cells, and treatment was started 13 days later when the primary tumors measured 5 mm in average diameter. Mice were randomly assigned to four treatment groups receiving: (1) control IgG (IgG), (2) RT + IgG, (3) 9H10 monoclonal antibody against CTLA-4, (4) RT + 9H10. RT was delivered to the primary tumor by one or two fractions of 12 Gy. 9H10 and IgG were given i.p. thrice after RT. RESULTS: Consistent with the fact that 4T1 is poorly immunogenic, 9H10 alone did not have any effect on primary tumor growth or survival. RT was able to delay the growth of the primary irradiated tumor, but in the absence of 9H10 survival was similar to that of control mice. In contrast, mice treated with RT + 9H10 had a statistically significant survival advantage. The increased survival correlated with inhibition of lung metastases formation and required CD8+ but not CD4+ T cells. CONCLUSIONS: The combination of local RT with CTLA-4 blockade is a promising new immunotherapeutic strategy against poorly immunogenic metastatic cancers.

Animals↗