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Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors.
Deppen SA, Liu E, Blume JD, Clanton J, Shi C, Jones-Jackson LB, Lakhani V, Baum RP, Berlin J, Smith GT, Graham M, Sandler MP, Delbeke D, Walker RC
(2016) J Nucl Med 57: 708-14
MeSH Terms: Female, Humans, Indium Radioisotopes, Intestinal Neoplasms, Lung Neoplasms, Male, Middle Aged, Neoplasm Staging, Neuroendocrine Tumors, Observer Variation, Organometallic Compounds, Pancreatic Neoplasms, Positron Emission Tomography Computed Tomography, Safety, Somatostatin, Stomach Neoplasms
Show Abstract · Added May 7, 2016
UNLABELLED - Our purpose was to evaluate the safety and efficacy of (68)Ga-DOTATATE PET/CT compared with (111)In-pentetreotide imaging for diagnosis, staging, and restaging of pulmonary and gastroenteropancreatic neuroendocrine tumors.
METHODS - (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were obtained for 78 of 97 consecutively enrolled patients with known or suspected pulmonary or gastroenteropancreatic neuroendocrine tumors. Safety and toxicity were measured by comparing vital signs, serum chemistry values, or acquisition-related medical complications before and after (68)Ga-DOTATATE injection. Added value was determined by changes in treatment plan when (68)Ga-DOTATATE PET/CT results were added to all prior imaging, including (111)In-pentetreotide. Interobserver reproducibility of (68)Ga-DOTATATE PET/CT scan interpretation was measured between blinded and nonblinded interpreters.
RESULTS - (68)Ga-DOTATATE PET/CT and (111)In-pentetreotide scans were significantly different in impact on treatment (P < 0.001). (68)Ga-DOTATATE PET/CT combined with CT or liver MRI changed care in 28 of 78 (36%) patients. Interobserver agreement between blinded and nonblinded interpreters was high. No participant had a trial-related event requiring treatment. Mild, transient events were tachycardia in 1, alanine transaminase elevation in 1, and hyperglycemia in 2 participants. No clinically significant arrhythmias occurred. (68)Ga-DOTATATE PET/CT correctly identified 3 patients for peptide-receptor radiotherapy incorrectly classified by (111)In-pentetreotide.
CONCLUSION - (68)Ga-DOTATATE PET/CT was equivalent or superior to (111)In-pentetreotide imaging in all 78 patients. No adverse events requiring treatment were observed. (68)Ga-DOTATATE PET/CT changed treatment in 36% of participants. Given the lack of significant toxicity, lower radiation exposure, and improved accuracy compared with (111)In-pentetreotide, (68)Ga-DOTATATE imaging should be used instead of (111)In-pentetreotide imaging where available.
© 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.
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16 MeSH Terms
Reproducibility of Differential Proteomic Technologies in CPTAC Fractionated Xenografts.
Tabb DL, Wang X, Carr SA, Clauser KR, Mertins P, Chambers MC, Holman JD, Wang J, Zhang B, Zimmerman LJ, Chen X, Gunawardena HP, Davies SR, Ellis MJ, Li S, Townsend RR, Boja ES, Ketchum KA, Kinsinger CR, Mesri M, Rodriguez H, Liu T, Kim S, McDermott JE, Payne SH, Petyuk VA, Rodland KD, Smith RD, Yang F, Chan DW, Zhang B, Zhang H, Zhang Z, Zhou JY, Liebler DC
(2016) J Proteome Res 15: 691-706
MeSH Terms: Breast Neoplasms, Chromatography, Liquid, Data Interpretation, Statistical, Female, Gene Expression Profiling, Heterografts, Humans, Metabolic Networks and Pathways, Observer Variation, Proteome, Proteomics, Quality Control, Reproducibility of Results, Tandem Mass Spectrometry
Show Abstract · Added February 15, 2016
The NCI Clinical Proteomic Tumor Analysis Consortium (CPTAC) employed a pair of reference xenograft proteomes for initial platform validation and ongoing quality control of its data collection for The Cancer Genome Atlas (TCGA) tumors. These two xenografts, representing basal and luminal-B human breast cancer, were fractionated and analyzed on six mass spectrometers in a total of 46 replicates divided between iTRAQ and label-free technologies, spanning a total of 1095 LC-MS/MS experiments. These data represent a unique opportunity to evaluate the stability of proteomic differentiation by mass spectrometry over many months of time for individual instruments or across instruments running dissimilar workflows. We evaluated iTRAQ reporter ions, label-free spectral counts, and label-free extracted ion chromatograms as strategies for data interpretation (source code is available from http://homepages.uc.edu/~wang2x7/Research.htm ). From these assessments, we found that differential genes from a single replicate were confirmed by other replicates on the same instrument from 61 to 93% of the time. When comparing across different instruments and quantitative technologies, using multiple replicates, differential genes were reproduced by other data sets from 67 to 99% of the time. Projecting gene differences to biological pathways and networks increased the degree of similarity. These overlaps send an encouraging message about the maturity of technologies for proteomic differentiation.
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14 MeSH Terms
Contrast-enhanced ultrasound evaluation of residual blood flow to hepatocellular carcinoma after treatment with transarterial chemoembolization using drug-eluting beads: a prospective study.
Shaw CM, Eisenbrey JR, Lyshchik A, O'Kane PL, Merton DA, Machado P, Pino L, Brown DB, Forsberg F
(2015) J Ultrasound Med 34: 859-67
MeSH Terms: Aged, Antineoplastic Agents, Carcinoma, Hepatocellular, Chemoembolization, Therapeutic, Contrast Media, Delayed-Action Preparations, Doxorubicin, Drug-Eluting Stents, Female, Hemostatics, Humans, Liver Neoplasms, Male, Middle Aged, Neovascularization, Pathologic, Observer Variation, Perfusion Imaging, Prognosis, Prospective Studies, Treatment Outcome, Ultrasonography
Show Abstract · Added September 18, 2015
OBJECTIVES - To evaluate the accuracy and change over time of contrast-enhanced ultrasound (US) imaging for assessing residual blood flow after transarterial chemoembolization of hepatocellular carcinoma with drug-eluting beads at 2 different follow-up intervals.
METHODS - Data from 16 tumors treated by transarterial chemoembolization with drug-eluting beads were successfully obtained. As part of the study, patients provided consent to undergo contrast-enhanced US examinations the morning before embolization, 1 to 2 weeks after embolization, and the morning before follow-up contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) (1 month after embolization). Blinded review of contrast-enhanced US and MRI/CT studies were performed by 2 radiologists who evaluated residual flow as no change, partial change, or no residual flow. Inter- and intra-reader variability rates were calculated before discordant individual reads were settled by consensus.
RESULTS - The only adverse event reported during the contrast-enhanced US examinations was a single episode of transient back pain. Contrast-enhanced US at 1 to 2 weeks after embolization (n = 14) resulted in 100% sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Contrast-enhanced US 1 month after embolization (n = 15) resulted in 75% sensitivity, 100% specificity, 100% positive predictive value, 92% negative predictive value, and 93% accuracy. Inter-reader agreement was 86% for contrast-enhanced US at 1 to 2 weeks, 93% for contrast-enhanced US at 1 month, and 100% for contrast-enhanced MRI/CT at 1 month, whereas intra-reader agreement was 71% for contrast-enhanced US at 1 to 2 weeks, 87% for contrast-enhanced US at 1 month, and 91% for MRI/CT.
CONCLUSIONS - Contrast-enhanced US imaging at 1 to 2 weeks after the procedure may be a viable alternative to MRI/CT for evaluating residual blood flow after transarterial chemoembolization with drug-eluting beads, albeit with a higher degree of reader variability.
© 2015 by the American Institute of Ultrasound in Medicine.
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21 MeSH Terms
7T MRI-Histologic Correlation Study of Low Specific Absorption Rate T2-Weighted GRASE Sequences in the Detection of White Matter Involvement in Multiple Sclerosis.
Bagnato F, Hametner S, Pennell D, Dortch R, Dula AN, Pawate S, Smith SA, Lassmann H, Gore JC, Welch EB
(2015) J Neuroimaging 25: 370-8
MeSH Terms: Absorption, Radiation, Adult, Aged, Algorithms, Brain, Diffusion Tensor Imaging, Female, Humans, Image Enhancement, Image Interpretation, Computer-Assisted, Male, Multiple Sclerosis, Observer Variation, Radiation Dosage, Radiation Protection, Reproducibility of Results, Sensitivity and Specificity, Signal Processing, Computer-Assisted, Statistics as Topic, White Matter
Show Abstract · Added April 30, 2015
BACKGROUND - The high value of the specific absorption rate (SAR) of radio-frequency (RF) energy arising from the series of RF refocusing pulses in T2-weighted (T2-w) turbo spin echo (TSE) MRI hampers its clinical application at 7.0 Tesla (7T). T2-w gradient and spin echo (GRASE) uses the speed from gradient refocusing in combination with the chemical-shift/static magnetic field (B0) inhomogeneity insensitivity from spin-echo refocusing to acquire T2-w images with a limited number of refocusing RF pulses, thus reducing SAR.
OBJECTIVES - To investigate whether low SAR T2-w GRASE could replace T2-w TSE in detecting white matter (WM) disease in MS patients imaged at 7T.
METHODS - The .7 mm3 isotropic T2-w TSE and T2-w GRASE images with variable echo times (TEs) and echo planar imaging (EPI) factors were obtained on a 7T scanner from postmortem samples of MS brains. These samples were derived from brains of 3 female MS patients. WM lesions (WM-Ls) and normal-appearing WM (NAWM) signal intensity, WM-Ls/NAWM contrast-to-noise ratio (CNR) and MRI/myelin staining sections comparisons were obtained.
RESULTS - GRASE sequences with EPI factor/TE = 3/50 and 3/75 ms were comparable to the SE technique for measures of CNR in WM-Ls and NAWM and for detection of WM-Ls. In all sequences, however, identification of areas with remyelination, Wallerian degeneration, and gray matter demyelination, as depicted by myelin staining, was not possible.
CONCLUSIONS - T2-w GRASE images may replace T2-w TSE for clinical use. However, even at 7T, both sequences fail in detecting and characterizing MS disease beyond visible WM-Ls.
Copyright © 2015 by the American Society of Neuroimaging.
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20 MeSH Terms
Inter-rater agreement on identification of electrographic seizures and periodic discharges in ICU EEG recordings.
Halford JJ, Shiau D, Desrochers JA, Kolls BJ, Dean BC, Waters CG, Azar NJ, Haas KF, Kutluay E, Martz GU, Sinha SR, Kern RT, Kelly KM, Sackellares JC, LaRoche SM
(2015) Clin Neurophysiol 126: 1661-9
MeSH Terms: Electroencephalography, Humans, Intensive Care Units, Observer Variation, Retrospective Studies, Seizures
Show Abstract · Added February 12, 2015
OBJECTIVE - This study investigated inter-rater agreement (IRA) among EEG experts for the identification of electrographic seizures and periodic discharges (PDs) in continuous ICU EEG recordings.
METHODS - Eight board-certified EEG experts independently identified seizures and PDs in thirty 1-h EEG segments which were selected from ICU EEG recordings collected from three medical centers. IRA was compared between seizure and PD identifications, as well as among rater groups that have passed an ICU EEG Certification Test, developed by the Critical Care EEG Monitoring Research Consortium (CCEMRC).
RESULTS - Both kappa and event-based IRA statistics showed higher mean values in identification of seizures compared to PDs (k=0.58 vs. 0.38; p<0.001). The group of rater pairs who had both passed the ICU EEG Certification Test had a significantly higher mean IRA in comparison to rater pairs in which neither had passed the test.
CONCLUSIONS - IRA among experts is significantly higher for identification of electrographic seizures compared to PDs. Additional instruction, such as the training module and certification test developed by the CCEMRC, could enhance this IRA.
SIGNIFICANCE - This study demonstrates more disagreement in the labeling of PDs in comparison to seizures. This may be improved by education about standard EEG nomenclature.
Published by Elsevier Ireland Ltd.
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6 MeSH Terms
Validation of the Confusion Assessment Method for the Intensive Care Unit in older emergency department patients.
Han JH, Wilson A, Graves AJ, Shintani A, Schnelle JF, Dittus RS, Powers JS, Vernon J, Storrow AB, Ely EW
(2014) Acad Emerg Med 21: 180-7
MeSH Terms: Aged, Aged, 80 and over, Confusion, Delirium, Emergency Service, Hospital, Female, Humans, Intensive Care Units, Likelihood Functions, Logistic Models, Male, Observer Variation, Prospective Studies, Psychiatric Status Rating Scales, Reproducibility of Results, Sensitivity and Specificity
Show Abstract · Added May 27, 2014
OBJECTIVES - In the emergency department (ED), health care providers miss delirium approximately 75% of the time, because they do not routinely screen for this syndrome. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a brief (<1 minute) delirium assessment that may be feasible for use in the ED. The study objective was to determine its validity and reliability in older ED patients.
METHODS - In this prospective observational cohort study, patients aged 65 years or older were enrolled at an academic, tertiary care ED from July 2009 to February 2012. An emergency physician (EP) and research assistants (RAs) performed the CAM-ICU. The reference standard for delirium was a comprehensive (~30 minutes) psychiatrist assessment using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria. All assessments were blinded to each other and were conducted within 3 hours. Sensitivities, specificities, and likelihood ratios were calculated for both the EP and the RAs using the psychiatrist's assessment as the reference standard. Kappa values between the EP and RAs were also calculated to measure reliability.
RESULTS - Of 406 patients enrolled, 50 (12.3%) had delirium. The median age was 73.5 years old (interquartile range [IQR] = 69 to 80 years), 202 (49.8%) were female, and 57 (14.0%) were nonwhite. The CAM-ICU's sensitivities were 72.0% (95% confidence interval [CI] = 58.3% to 82.5%) and 68.0% (95% CI = 54.2% to 79.2%) in the EP and RAs, respectively. The CAM-ICU's specificity was 98.6% (95% CI = 96.8% to 99.4%) for both raters. The negative likelihood ratios (LR-) were 0.28 (95% CI = 0.18 to 0.44) and 0.32 (95% CI = 0.22 to 0.49) in the EP and RAs, respectively. The positive likelihood ratios (LR+) were 51.3 (95% CI = 21.1 to 124.5) and 48.4 (95% CI = 19.9 to 118.0), respectively. The kappa between the EP and RAs was 0.92 (95% CI = 0.85 to 0.98), indicating excellent interobserver reliability.
CONCLUSIONS - In older ED patients, the CAM-ICU is highly specific, and a positive test is nearly diagnostic for delirium when used by both the EP and RAs. However, the CAM-ICU's sensitivity was modest, and a negative test decreased the likelihood of delirium by a small amount. The consequences of a false-negative CAM-ICU are unknown and deserve further study.
© 2014 by the Society for Academic Emergency Medicine.
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16 MeSH Terms
Self-assessed performance improves statistical fusion of image labels.
Bryan FW, Xu Z, Asman AJ, Allen WM, Reich DS, Landman BA
(2014) Med Phys 41: 031903
MeSH Terms: Algorithms, Automation, Humans, Image Interpretation, Computer-Assisted, Image Processing, Computer-Assisted, Magnetic Resonance Imaging, Models, Statistical, Observer Variation, Pattern Recognition, Automated, Reproducibility of Results, Software, Spinal Cord
Show Abstract · Added March 26, 2014
PURPOSE - Expert manual labeling is the gold standard for image segmentation, but this process is difficult, time-consuming, and prone to inter-individual differences. While fully automated methods have successfully targeted many anatomies, automated methods have not yet been developed for numerous essential structures (e.g., the internal structure of the spinal cord as seen on magnetic resonance imaging). Collaborative labeling is a new paradigm that offers a robust alternative that may realize both the throughput of automation and the guidance of experts. Yet, distributing manual labeling expertise across individuals and sites introduces potential human factors concerns (e.g., training, software usability) and statistical considerations (e.g., fusion of information, assessment of confidence, bias) that must be further explored. During the labeling process, it is simple to ask raters to self-assess the confidence of their labels, but this is rarely done and has not been previously quantitatively studied. Herein, the authors explore the utility of self-assessment in relation to automated assessment of rater performance in the context of statistical fusion.
METHODS - The authors conducted a study of 66 volumes manually labeled by 75 minimally trained human raters recruited from the university undergraduate population. Raters were given 15 min of training during which they were shown examples of correct segmentation, and the online segmentation tool was demonstrated. The volumes were labeled 2D slice-wise, and the slices were unordered. A self-assessed quality metric was produced by raters for each slice by marking a confidence bar superimposed on the slice. Volumes produced by both voting and statistical fusion algorithms were compared against a set of expert segmentations of the same volumes.
RESULTS - Labels for 8825 distinct slices were obtained. Simple majority voting resulted in statistically poorer performance than voting weighted by self-assessed performance. Statistical fusion resulted in statistically indistinguishable performance from self-assessed weighted voting. The authors developed a new theoretical basis for using self-assessed performance in the framework of statistical fusion and demonstrated that the combined sources of information (both statistical assessment and self-assessment) yielded statistically significant improvement over the methods considered separately.
CONCLUSIONS - The authors present the first systematic characterization of self-assessed performance in manual labeling. The authors demonstrate that self-assessment and statistical fusion yield similar, but complementary, benefits for label fusion. Finally, the authors present a new theoretical basis for combining self-assessments with statistical label fusion.
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12 MeSH Terms
Age-related changes of hyoid bone position in healthy older adults with aspiration.
Feng X, Todd T, Hu Y, Lintzenich CR, Carr JJ, Browne JD, Kritchevsky SB, Butler SG
(2014) Laryngoscope 124: E231-6
MeSH Terms: Adult, Age Factors, Aged, Aged, 80 and over, Aging, Cohort Studies, Deglutition, Deglutition Disorders, Female, Humans, Hyoid Bone, Imaging, Three-Dimensional, Linear Models, Male, Mandible, Multivariate Analysis, Observer Variation, Reference Values, Reproducibility of Results, Respiratory Aspiration, Retrospective Studies, Risk Assessment, Sex Factors, Tomography, X-Ray Computed, Young Adult
Show Abstract · Added February 15, 2014
OBJECTIVES/HYPOTHESIS - Aspiration, the passage of a bolus below the vocal folds, increases morbidity and mortality in the elderly by increasing the risk of aspiration pneumonia and other conditions. We hypothesized that altered position of the hyoid bone associated with aging may negatively affect airway protection during swallowing (i.e., aspiration) in older adults.
STUDY DESIGN - Retrospective study.
METHODS - We re-reviewed computed tomography (CT) scans of the head from 40 older adults (65-80 years old), comprised of 20 aspirators and 20 nonaspirators, obtained from a previous cohort study. In addition, CT scans of the head from 40 young adults (20-40 years old) were retrieved from a medical records database. Three-dimensional reconstruction and 2-dimensional sagittal views were used to measure the distance between the mandible and hyoid bone. Comparisons between age groups, genders, and aspiration status were made.
RESULTS - Older adults had a larger distance between the hyoid and mandible in both latitude and longitudinal positions compared to the young adults. Among older males, there was evidence that the hyoid bone in the aspirators tended to be positioned more posterior compared to the nonaspirators.
CONCLUSIONS - The distance between the hyoid and mandible is increased with aging, and a more posterior position of the hyoid bone is correlated with aspiration in older males. These findings suggest that age-related changes in hyoid bone position may be a component of decreased swallowing safety and aspiration in older adults and warrant further investigation.
LEVEL OF EVIDENCE - N/A.
© 2013 The American Laryngological, Rhinological and Otological Society, Inc.
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25 MeSH Terms
Automated classification of spatiotemporal characteristics of gastric slow wave propagation.
Paskaranandavadivel N, Gao J, Du P, O'Grady G, Cheng LK
(2013) Conf Proc IEEE Eng Med Biol Soc 2013: 7342-5
MeSH Terms: Algorithms, Analysis of Variance, Animals, Electronic Data Processing, Observer Variation, Reproducibility of Results, Signal Processing, Computer-Assisted, Stomach, Swine
Show Abstract · Added April 26, 2016
Gastric contractions are underpinned by an electrical event called slow wave activity. High-resolution electrical mapping has recently been adapted to study gastric slow waves at a high spatiotemporal detail. As more slow wave data becomes available, it is becoming evident that the spatial organization of slow wave plays a key role in the initiation and maintenance of gastric dsyrhythmias in major gastric motility disorders. All of the existing slow wave signal processing techniques deal with the identification and partitioning of recorded wave events, but not the analysis of the slow wave spatial organization, which is currently performed visually. This manual analysis is time consuming and is prone to observer bias and error. We present an automated approach to classify spatial slow wave propagation patterns via the use of Pearson cross correlations. Slow wave propagations were grouped into classes based on their similarity to each other. The method was applied to high-resolution gastric slow wave recordings from four pigs. There were significant changes in the velocity of the gastric slow wave wavefront and the amplitude of the slow wave event when there was a change in direction to the slow wave wavefront during dsyrhythmias, which could be detected with the automated approach.
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9 MeSH Terms
Early assessment of breast cancer response to neoadjuvant chemotherapy by semi-quantitative analysis of high-temporal resolution DCE-MRI: preliminary results.
Abramson RG, Li X, Hoyt TL, Su PF, Arlinghaus LR, Wilson KJ, Abramson VG, Chakravarthy AB, Yankeelov TE
(2013) Magn Reson Imaging 31: 1457-64
MeSH Terms: Adult, Area Under Curve, Breast Neoplasms, Chemotherapy, Adjuvant, Computer Graphics, Contrast Media, Female, Humans, Magnetic Resonance Imaging, Middle Aged, Neoadjuvant Therapy, Observer Variation, Prospective Studies, Time Factors, Treatment Outcome
Show Abstract · Added March 7, 2014
PURPOSE - To evaluate whether semi-quantitative analysis of high temporal resolution dynamic contrast-enhanced MRI (DCE-MRI) acquired early in treatment can predict the response of locally advanced breast cancer (LABC) to neoadjuvant chemotherapy (NAC).
MATERIALS AND METHODS - As part of an IRB-approved prospective study, 21 patients with LABC provided informed consent and underwent high temporal resolution 3T DCE-MRI before and after 1cycle of NAC. Using measurements performed by two radiologists, the following parameters were extracted for lesions at both examinations: lesion size (short and long axes, in both early and late phases of enhancement), radiologist's subjective assessment of lesion enhancement, and percentages of voxels within the lesion demonstrating progressive, plateau, or washout kinetics. The latter data were calculated using two filters, one selecting for voxels enhancing ≥50% over baseline and one for voxels enhancing ≥100% over baseline. Pretreatment imaging parameters and parameter changes following cycle 1 of NAC were evaluated for their ability to discriminate patients with an eventual pathological complete response (pCR).
RESULTS - All 21 patients completed NAC followed by surgery, with 9 patients achieving a pCR. No pretreatment imaging parameters were predictive of pCR. However, change after cycle 1 of NAC in percentage of voxels demonstrating washout kinetics with a 100% enhancement filter discriminated patients with an eventual pCR with an area under the receiver operating characteristic curve (AUC) of 0.77. Changes in other parameters, including lesion size, did not predict pCR.
CONCLUSION - Semi-quantitative analysis of high temporal resolution DCE-MRI in patients with LABC can discriminate patients with an eventual pCR after one cycle of NAC.
© 2013 Elsevier Inc. All rights reserved.
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15 MeSH Terms