A strategy for quality control of ginkgo biloba preparations based on UPLC fingerprint analysis and multi-component separation combined with quantitative analysis.

BACKGROUND: Many studies have assessed the fingerprint and quantitative analysis of Ginkgo biloba preparations, but the fingerprint mainly focuses on flavonoid glycosides. However, according to our previous study, the differences among diverse manufacturers mainly involve organic acids. METHODS: A novel reverse-phase liquid chromatography assay using diode array detection was developed for evaluating Ginkgo biloba preparations for quality based on a chromatographic fingerprint allowing the simultaneous assessment of eleven compounds, including four organic acids, six flavonol glycosides and one flavonoid aglycone. And the method was applied to 51 batches of Ginkgo biloba preparations from manufacturers in China. Chemometric approaches were performed for evaluating 51 batches of Ginkgo biloba preparations from various manufacturers. RESULTS: The similarity values among the chromatograms of 51 samples ranged from 0.45 to 1.00, showing that the quality of Ginkgo biloba preparations produced by different manufacturers varied greatly. Data analysis of the 51 batches of GBP samples suggested significant variations of the total contents of all 11 targets, also demonstrating the quality difference of GBP samples. There were significant differences in organic acids in particular. CONCLUSION: Combining the chemical fingerprint and quantitative assessment revealed significant variations in the examined commercial products with regard to organic acids. Thus, this study provided a more comprehensive tool for monitoring the quality consistency of Ginkgo biloba preparations.

Radiomics analysis enables fatal outcome prediction for hospitalized patients with coronavirus disease 2019 (COVID-19).

BACKGROUND: In December 2019, a rare respiratory disease named coronavirus disease 2019 (COVID-19) broke out, leading to great concern around the world. PURPOSE: To develop and validate a radiomics nomogram for predicting the fatal outcome of COVID-19 pneumonia. MATERIAL AND METHODS: The present study consisted of a training dataset (n = 66) and a validation dataset (n = 30) with COVID-19 from January 2020 to March 2020. A radiomics signature was generated using the least absolute shrinkage and selection operator (LASSO) Cox regression model. A radiomics score (Rad-score) was developed from the training cohort. The radiomics model, clinical model, and integrated model were built to assess the association between radiomics signature/clinical characteristics and the mortality of COVID-19 cases. The radiomics signature combined with the Rad-score and the independent clinical factors and radiomics nomogram were constructed. RESULTS: Seven stable radiomics features associated with the mortality of COVID-19 were finally selected. A radiomics nomogram was based on a combined model consisting of the radiomics signature and the clinical risk factors indicating optimal predictive performance for the fatal outcome of patients with COVID-19 with a C-index of 0.912 (95% confidence interval [CI] 0.867-0.957) in the training dataset and 0.907 (95% CI 0.849-0.966) in the validation dataset. The calibration curves indicated optimal consistency between the prediction and the observation in both training and validation cohorts. CONCLUSION: The CT-based radiomics nomogram indicated favorable predictive efficacy for the overall survival risk of patients with COVID-19, which could help clinicians intensively follow up high-risk patients and make timely diagnoses.

Establishment of determination method for five Ginkgo biflavones in Ginkgo biloba leaves tablets / 中国药房

OBJECTIVE To establish a met hod for the determination of amentoflavone ，bilobetin，ginkgetin，isoginkgetin and sciadopitysin in Ginkgo biloba leaves tablets. METHODS After extracted with methanol ，ultra-performance liquid chromatography （UPLC）was adopted to determine G. biloba leaves tablets. The determination was performed on Waters Acquity UPLC HSS T 3 column with acetonitrile- 0.4％ phosphoric acid as mobile phase （gradient elution ）at the flow rate of 0.4 mL/min. The column temperature was set at 35 ℃，and the detection wavelength was 340 nm. The sample size were 1 μL（substance control ）and 10 μL （test sample ）. The relative correction factors （RCFs）of bilobetin ，ginkgetin，isoginkgetin and sciadopitysin were calculated by quantitative analysis of multicomponents by single marker （QAMS）using amentoflavone as control. The chromatographic peak was located with the relative retention time method. Then the contents of the above components were calculated ，and the results were compared with those of external standard method （ESM）（except for amentoflavone ）. RESULTS The linear ranges of amentoflavone，bilobetin，ginkgetin，isoginkgetin and sciadopitysin were 0.10-8.21，0.24-19.34，0.16-12.98，0.22-17.66，0.06-4.86 ng，respectively（all r＞0.999）. The quantitation limits were 0.10，0.24，0.16，0.22，0.06 ng，respectively. RSDs of precision ， repeatability and stability tests （36 h）were all lower than 3.00％. The average recoveries were 99.77％-102.85％，and RSDs were 1.90％-4.40％（n＝6）. The average RCFs of bilobetin ，ginkgetin，isoginkgetin and sciadopitysin were 0.91，0.93，0.96 and 0.95， respectively. The average relative retention times were 1.08，1.18，1.19 and 1.30，respectively. The relative deviation between the calculation result of QAMS and ESM was within ±3.00％. CONCLUSIONS The established method is accurate and stable ，and can be applied to the determination of Ginkgo biflavones in G. biloba leaves tablets and control the quality.

Development and multicenter validation of a CT-based radiomics signature for predicting severe COVID-19 pneumonia.

OBJECTIVES: To develop and validate a radiomics nomogram for timely predicting severe COVID-19 pneumonia. MATERIALS AND METHODS: Three hundred and sixteen COVID-19 patients (246 non-severe and 70 severe) were retrospectively collected from two institutions and allocated to training, validation, and testing cohorts. Radiomics features were extracted from chest CT images. Radiomics signature was constructed based on reproducible features using the least absolute shrinkage and selection operator (LASSO) logistic regression algorithm with 5-fold cross-validation. Logistic regression modeling was employed to build different models based on quantitative CT features, radiomics signature, clinical factors, and/or the former combined features. Nomogram performance for severe COVID-19 prediction was assessed with respect to calibration, discrimination, and clinical usefulness. RESULTS: Sixteen selected features were used to build the radiomics signature. The CT-based radiomics model showed good calibration and discrimination in the training cohort (AUC, 0.9; 95% CI, 0.843-0.942), the validation cohort (AUC, 0.878; 95% CI, 0.796-0.958), and the testing cohort (AUC, 0.842; 95% CI, 0.761-0.922). The CT-based radiomics model showed better discrimination capability (all p < 0.05) compared with the clinical factors joint quantitative CT model (AUC, 0.781; 95% CI, 0.708-0.843) in the training cohort, the validation cohort (AUC, 0.814; 95% CI, 0.703-0.897), and the testing cohort (AUC, 0.696; 95% CI, 0.581-0.796). Decision curve analysis demonstrated that in terms of clinical usefulness, the radiomics model outperformed the clinical factors model and quantitative CT model alone. CONCLUSIONS: The CT-based radiomics signature shows favorable predictive efficacy for severe COVID-19, which might assist clinicians in tailoring precise therapy. KEY POINTS: • Radiomics can be applied in CT images of COVID-19 and radiomics signature was an independent predictor of severe COVID-19. • CT-based radiomics model can predict severe COVID-19 with satisfactory accuracy compared with subjective CT findings and clinical factors. • Radiomics nomogram integrated with the radiomics signature, subjective CT findings, and clinical factors can achieve better severity prediction with improved diagnostic performance.

Determination and Risk Assessment of Six Hepatotoxic Pyrrolizidine Alkaloids in Verbenae Herba / 中国实验方剂学杂志

Objective:To establish ultra-performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） for simultaneous determination of six hepatotoxic pyrrolizidine alkaloids in Verbenae Herba， and to carry out preliminary risk assessment according to the research results. Method:An ACQUITY UPLC HSS T3 column （2.1 mm×100 mm， 1.8 μm） was used for analysis with 0.05% formic acid and 2.5 mmol·L^-1 ammonium formate in water （A）-0.05% formic acid and 2.5 mmol·L^-1 ammonium formate in acetonitrile （B） as mobile phase for gradient elution （0-12 min， 3%-8%B； 12-25 min， 8%-15%B； 25-26 min， 15%-3%B； 26-30 min， 3%B）， the flow rate was 0.3 mL·min^-1， the column temperature was 40 ℃， and the injection volume was 1 μL. MS system was operated by electrospray ionization （ESI） in the positive ion mode with multiple reaction monitoring mode. MS parameters of triple quadrupole and six analytes were optimized for qualitative and quantitative analysis. According to the determination results， the risk assessment was carried out by using margin of exposure （MOE） combined with transfer rate of hot water extraction. Result:Based on the instrument precision， linear range， repeatability， stability， recovery and other methodological validations， the results were in conformity with relevant standards of quantitative analysis. The linear ranges of intermedine， lycopsamine， intermedine <italic>N</italic>-oxide， lycopsamine<italic> N</italic>-oxide， echimidine<italic> N</italic>-oxide and echimidine were good （<italic>r</italic>≥0.999 0） between peak area and mass concentration in the ranges of 0.984-49.20， 0.994-49.70， 1.012-50.60， 1.032-51.60， 1.004-50.20， 1.016-50.80 µg·L^-1， respectively. The average recoveries of these six analytes were 87.2%-94.2% with relative standard deviation （RSD）<4.0%. Their MOE values were >10 000. Conclusion:The UPLC-MS/MS established in this study is stable and feasible， which can provide scientific basis for the quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloids in Verbenae Herba.

Quality Analysis and Suggestion for Ginkgo Folium Tablets and Ginkgo Folium Capsules / 中国实验方剂学杂志

Objective:To conduct quality evaluation of Ginkgo Folium preparations by analyzing the national evaluation sampling test results， analyze the quality differences， and put forward suggestions for the improvement of quality standards and market supervision. Method:The contents of total flavonol glycosides and terpene lactones in Ginkgo Folium tablets and Ginkgo Folium capsules were determined according to the methods of determination in the 2015 edition of Chinese Pharmacopoeia （the first volume）， and the contents of free flavonoids （quercetin， kaempferide and isorhamnetin） and sophoricoside in Ginkgo Folium preparations were determined according to related supplementary testing method of Ginkgo Folium tablets and Ginkgo Folium capsules issued by National Medical Products Administration. The quality differences of Ginkgo Folium preparations from different batches and different manufacturers were compared according to the contents of total flavonol glycosides， terpene lactones， free flavonoids and sophoricoside in 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules manufactured by 48 enterprises. Result:Quality of 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules was in accordance with the standard， but the contents of terpene lactones and total flavonol glycosides were all distributed in a wide range， and the quality of samples varied greatly among different enterprises. Conclusion:It is recommended that each enterprise should optimize the production process and strictly control the raw materials to ensure the consistency between different batches of samples.

Simultaneous determination of six pyrrolizidine alkaloids in different parts of Emilia sonchifolia by UPLC-MS/MS / 中国中药杂志

This study aims to develop a UPLC-MS/MS method for simultaneous determination of six pyrrolizidine alkaloids(PAs)--intermedine N-oxide(ImNO), lycopsamine N-oxide(LyNO), seneciphylline(Sp), seneciphylline N-oxide(SpNO), senecionine N-oxide(SnNO), and senkirkine(Sk) in different parts of Emilia sonchifolia. UPLC conditions are as follows: ACQUITY UPLC HSS T3 column(2.1 mm×100 mm, 1.8 μm), mobile phase consisting of 0.05% formic acid and 2.5 mmol·L~(-1) ammonium formate in water(A)-0.05% formic acid and 2.5 mmol·L~(-1) ammonium formate in acetonitrile(B) for gradient elution. MS conditions are as below: electrospray ionization(ESI) in the positive ion mode, multiple reaction monitoring(MRM), and the content of the six PAs was calculated with the external standard method. The results suggested the differences in the six PAs among different parts of E. sonchifolia. Sk was detected in all the four parts, with similar content. SnNO also existed in all the four parts, but the content in roots was significantly higher than that in other parts. Sp and SpNO were found in both roots and flowers, with the content higher in the former than in the later. ImNO and LyNO were only found in leaves, and the content was low. Among the six components detected, ImNO, LyNO, and SpNO were found and determined for the first time, which enriched the toxic components and laid a scientific basis for the quality and safety evaluation of E. sonchifolia.

Content determination of eight phenols in Ilex hainanensis harvested at different time by HPLC-DAD / 中国中药杂志

This study intends to develop a high performance liquid chromatography-diode array detection(HPLC-DAD) method for simultaneous determination of chlorogenic acid, 2-hydroxymethyl-3-hydroxyl-1-butene-4-O-β-D-(6″-O-caffeoyl)-glucopyranoside, pubescenoside B, huazhongilexone-7-O-β-D-glucopyranoside, rutin, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C in Ilex hainanensis. The HPLC conditions are as follows: Waters XBridge C_(18 )column(4.6 mm×250 mm, 5 μm), mobile phase of 0.5% formic acid in water(A)-acetonitrile(B), gradient elution(0-8 min, 5%-12% B; 8-18 min, 12%-18% B; 18-30 min, 18%-25% B; 30-40 min, 25%-30% B; 40-42 min, 30%-80% B; 42-45 min, 80% B) at the flow rate of 0.8 mL·min~(-1), detection wavelengths of 282, 324, and 360 nm, column temperature of 25 ℃, and injection volume of 5 μL. The content of the 8 phenols in 8 samples was 0.30-6.29, 0.29-3.27, 0.15-10.4, 0.51-5.85, 0.49-9.02, 0.51-4.68, 1.93-13.4, and 0.87-5.95 mg·g~(-1), respectively. Moreover, the content of phenols in the samples collected in October was higher than that of samples harvested in other months. The established method is accurate and sensitive for the determination of phenols in I. hainanensis, which is useful for the quality improvement of this herbal medicine.

HPLC specific chromatogram of Vernonia anthelmintica and determination of six components / 中国中药杂志

This work aims to establish an HPLC specific chromatogram and determine six components of Vernonia anthelmintica with chlorogenic acid, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C, scutellarein and luteolin as index components. HPLC analysis was performed on a Waters Xbridge C_(18) column(4.6 mm×250 mm, 5 μm) with gradient elution of acetonitrile-0.05% trifluoroacetic acid solution at a flow rate of 1.0 mL·min~(-1). The detection wave length was 360 nm and the column temperature was 30 ℃. Chemometrics software Chempattern was employed to analyze the data. HPLC specific chromatogram of V. anthelmintica was established and six characteristic peaks were marked. Six characteristic peaks were simultaneously determined by HPLC within 50 min. The contents of the six components in 13 batch samples of V. anthelmintica were 0.14%-0.68%, 0.44%-0.74%, 0.63%-1.01%, 0.14%-0.71%, 0.15%-0.26% and 0.010%-0.030%, respectively. The HPLC specific chromatogram of V. anthelmintica, together with determination of six components showed strong specificity, and it can be used for the quality control of the crude drug.

Simultaneous determination of 6 main components in Achilleae Herba by HPLC / 中国中药杂志

This study aims to establish an HPLC method for the simultaneous determination of 6 main components, including chlorogenic acid, 3,4-dicaffeoylquinic acid,3,5-dicaffeoylquinic acid,4,5-dicaffeoylquinic acid, pellitorine and neopellitorine B in Achil-leae Herba. HPLC analysis was performed on a Merck Purospher STAR RP-18 endcapped(4.6 mm×250 mm, 5 μm), with a mobile phase consisting of 0.05% phosphoric acid solution(A)-acetonitrile(B) at a flow rate of 1 mL·min~(-1)(0-7 min,12%-14% B;7-10 min,14%-17% B;10-25 min,17%-22% B;25-35 min,22%-35% B;35-51 min,35%-80% B;51-60 min,80%-90% B). The detection wavelength was 254 nm and the column temperature maintained at 30 ℃, and the injection volume was 5 μL. The standard curves revealed a good linear relationship. The contents of 6 components were 0.404%-2.116% for chlorogenic acid, 0.160%-0.892% for 3,4-dicaffeoylquinic acid, 0.608%-1.464% for 3,5-dicaffeoylquinic acid, 0.168%-0.868% for 4,5-dicaffeoylquinic acid, 0.122%-1.234% for pellitorine, 0.065%-0.312% for neopellitorine B, respectively. Both cluster and principal component analysis can distinguish the research data in anthesis and pre-anthesis by software Chempattern. There were obviously differences in the different harvest time. Therefore, attention should be paid to the harvesting time of the herb. The method can be used to determine the contents of six main components, and can provide reference for the improvement of quality standard of Achilleae Herba.

Validation of SE-EPI-based T2 mapping for characterization of prostate cancer: a new method compared with the traditional CPMG method.

PURPOSE: We aim to compare the results of spin echo-echo planar imaging (SE-EPI)-based T2 mapping with those of the conventional Carr-Purcell-Meiboom-Gill (CPMG) method and to investigate the potential validity of SE-EPI-T2 mapping for the characterization of prostate cancer (PCa). METHODS: Our retrospective study included 42 PCa patients and 42 noncancer patients who underwent 3.0T MRI with b values ranging from 0 to 2000 s/mm2 and echo times (TEs) ranging from 32 to 100 ms before biopsies. Bland-Altman analysis was used to compare the agreement between the two methods. The correlations between CPMG-T2 values and SE-EPI-T2 values at different b values were determined by Spearman's rho analysis or Pearson analysis. The Mann-Whitney U test and two-sample t tests were used to analyze the differences between the cancerous and noncancerous groups. RESULTS: Substantial agreement regarding the measurements was observed between the two methods. The average correlation between the CPMG-T2 values and SE-EPI-T2 values was moderate and positive, and the best correlations were found at b = 200 s/mm2 in the noncancer group (r = 0.557, P = 0.000) and at b = 100 s/mm2 in the cancer group (r = 0.537, P = 0.000). In addition, statistically significant differences were found between the noncancer and cancer groups in T2 values and ADC values (diff TEs) (P = 0.000). CONCLUSIONS: Substantial agreement in the measurements was found between the SE-EPI method and CPMG method. SE-EPI-based T2 mapping has potential clinical value for the prostate and can be considered an alternative to the traditional CPMG-T2 mapping method.

Multi-parametric MRI-based radiomics signature for discriminating between clinically significant and insignificant prostate cancer: Cross-validation of a machine learning method.

PURPOSE: To evaluate the performance of a multi-parametric MRI (mp-MRI)-based radiomics signature for discriminating between clinically significant prostate cancer (csPCa) and insignificant PCa (ciPCa). MATERIALS AND METHODS: Two hundred and eighty patients with pathology-proven PCa were enrolled and were randomly divided into training and test cohorts. Eight hundred and nineteen radiomics features were extracted from mp-MRI for each patient. The minority group in the training cohort was balanced via the synthetic minority over-sampling technique (SMOTE) method. We used minimum-redundancy maximum-relevance (mRMR) selection and the LASSO algorithm for feature selection and radiomics signature building. The classification performance of the radiomics signature for csPCa and ciPCa was evaluated by receiver operating characteristic curve analysis in the training and test cohorts. RESULTS: Nine features were selected for the radiomics signature building. Significant differences in the radiomics signature existed between the csPCa and ciPCa groups in both the training and test cohorts (p < 0.01 for both). The AUC, sensitivity and specificity of the radiomics signature were 0.872 (95% CI: 0.823-0.921), 0.883, and 0.753, respectively, in the training cohort, and 0.823 (95% CI: 0.669-0.976), 0.841, and 0.727, respectively, in the test cohort. CONCLUSION: Mp-MRI-based radiomics signature have the potential to noninvasively discriminate between csPCa and ciPCa.

Comparative studies of three Cistanche speices based on UPLC specific chromatogram and determination of main components / 中国中药杂志

Based on UPLC specific chromatogram and determination of seven main components,this study aimed at evaluating the quality of Cistanche deserticola,C. tubulosa and C. sinensis. Echinacoside,cistanoside A,verbascoside,tubuloside A,isoacteoside,2'-acetylacteoside,tubuloside B were used as reference substances. UPLC analysis was performed on a Waters ACQUITY UPLC HSS T3 column( 2. 1 mm×100 mm,1. 8 μm). The mobile phase was acetonitrile-0. 08% trifluoroacetic acid solution. The flow rate was0. 3 mL·min-1,and the injection amount was 10 μL. The column temperature was 40 ℃,and the detection wavelength was 330 nm.The UPLC specific chromatograms were processed with ChemPattern software. UPLC specific chromatograms of C. deserticola and C.tubulosa from different samples were of high similarity,but the similarities of their counterfeit C. sinensis were less than 0. 06. Both of cluster and principal component analysis can distinguish certified products and counterfeits. The content ratios of echinacoside/verbascoside and verbascoside/isoacteoside were quite different between C. deserticola and C. tubulosa,which had distinct significance.The UPLC specific chromatogram and contents of seven main components can provide a basis for quality evaluation of Cistanches Herba.

Comparative study for freeze-drying and sun-drying on multi-index ingredients of Cordyceps sinensis / 中国中药杂志

The aim of this paper was to compare the influence of freeze-drying and sun-drying on six main nucleosides and nucleobases of Cordyceps sinensis by HPLC. Hypoxanthine,xanthine,uridine,inosine,guanosine and adenosine were reference substances. HPLC analysis was performed on a GL Inertsustain AQ-C_(18) column( 4. 6 mm×250 mm,5 μm),with mobile phase consisting of water( A)-acetonitrile( B) at the flow rate of 1. 0 mL·min~(-1)( 0-10 min,0-1% B; 10-65 min,1%-3% B). The detection wavelength was 260 nm,the column temperature was controlled at 30 ℃,and the injection volume was 5 μL. The linear ranges of hypoxanthine,xanthine,uridine,inosine,guanosine and adenosine were 1. 025-20. 50( r = 0. 999 8),0. 545-10. 90( r = 0. 999 9),4. 051-81. 02( r = 0. 999 8),4. 044-80. 88( r= 0. 999 9),2. 075-41. 50( r= 0. 999 9),4. 032-80. 64( r = 0. 999 9) mg·L~(-1),respectively. The average recoveries of them( n = 6)were as follows: 102. 3%( RSD 2. 1%),101. 1%( RSD 2. 4%),97. 80%( RSD 1. 7%),101. 8%( RSD 1. 8%),98. 90%( RSD2. 0%) and 98. 10%( RSD 1. 4%),respectively. Each sample was processed by freeze-drying and sun-drying so as to compare the difference between the two drying methods. The contents of six index ingredients were significantly different between freeze-drying and sun-drying sample of C. sinensis. The total contents of six index ingredients in sun-drying sample were higher than that in the corresponding freeze-drying sample. This research results provide the scientific basis for the drying methods and quality evaluation of C. sinensis.

Diagnostic Performance and Interobserver Consistency of the Prostate Imaging Reporting and Data System Version 2: A Study on Six Prostate Radiologists with Different Experiences from Half a Year to 17 Years.

BACKGROUND: One of the main aims of the updated Prostate Imaging Reporting and Data System Version 2 (PI-RADS v2) is to diminish variation in the interpretation and reporting of prostate imaging, especially among readers with varied experience levels. This study aimed to retrospectively analyze diagnostic consistency and accuracy for prostate disease among six radiologists with different experience levels from a single center and to evaluate the diagnostic performance of PI-RADS v2 scores in the detection of clinically significant prostate cancer (PCa). METHODS: From December 2014 to March 2016, 84 PCa patients and 99 benign prostatic shyperplasia patients who underwent 3.0T multiparametric magnetic resonance imaging before biopsy were included in our study. All patients received evaluation according to the PI-RADS v2 scale (1-5 scores) from six blinded readers (with 6 months and 2, 3, 4, 5, or 17 years of experience, respectively, the last reader was a reviewer/contributor for the PI-RADS v2). The correlation among the readers' scores and the Gleason score (GS) was determined with the Kendall test. Intra-/inter-observer agreement was evaluated using κ statistics, while receiver operating characteristic curve and area under the curve analyses were performed to evaluate the diagnostic performance of the scores. RESULTS: Based on the PI-RADS v2, the median κ score and standard error among all possible pairs of readers were 0.506 and 0.043, respectively; the average correlation between the six readers' scores and the GS was positive, exhibiting weak-to-moderate strength (r = 0.391, P = 0.006). The AUC values of the six radiologists were 0.883, 0.924, 0.927, 0.932, 0.929, and 0.947, respectively. CONCLUSION: The inter-reader agreement for the PI-RADS v2 among the six readers with different experience is weak to moderate. Different experience levels affect the interpretation of MRI images.

Using the prostate imaging reporting and data system version 2 (PI-RIDS v2) to detect prostate cancer can prevent unnecessary biopsies and invasive treatment.

Prostate cancer (PCa) is one of the most common cancers among men globally. The authors aimed to evaluate the ability of the Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) to classify men with PCa, clinically significant PCa (CSPCa), or no PCa, especially among those with serum total prostate-specific antigen (tPSA) levels in the "gray zone" (4-10 ng ml-1). A total of 308 patients (355 lesions) were enrolled in this study. Diagnostic efficiency was determined. Univariate and multivariate analyses, receiver operating characteristic curve analysis, and decision curve analysis were performed to determine and compare the predictors of PCa and CSPCa. The results suggested that PI-RADS v2, tPSA, and prostate-specific antigen density (PSAD) were independent predictors of PCa and CSPCa. A PI-RADS v2 score ≥4 provided high negative predictive values (91.39% for PCa and 95.69% for CSPCa). A model of PI-RADS combined with PSA and PSAD helped to define a high-risk group (PI-RADS score = 5 and PSAD ≥0.15 ng ml-1 cm-3, with tPSA in the gray zone, or PI-RADS score ≥4 with high tPSA level) with a detection rate of 96.1% for PCa and 93.0% for CSPCa while a low-risk group with a detection rate of 6.1% for PCa and 2.2% for CSPCa. It was concluded that the PI-RADS v2 could be used as a reliable and independent predictor of PCa and CSPCa. The combination of PI-RADS v2 score with PSA and PSAD could be helpful in the prediction and diagnosis of PCa and CSPCa and, thus, may help in preventing unnecessary invasive procedures.

Effects of Echo Time on IVIM Quantification of the Normal Prostate.

The two-compartment intravoxel incoherent motion (IVIM) theory assumes that the transverse relaxation time is the same in both compartments. However, blood and tissue have different T2 values, and echo time (TE) may thus have an effect on the quantitative parameters of IVIM. The purpose of this study was to investigate the effects of TE on IVIM-DWI-derived parameters of the prostate. In total, 17 healthy volunteers underwent two repeat examinations. IVIM-DWI data were scanned 6 times with variable TE values of 60, 70, 80, 90, 100, and 120 ms. The ADC of a mono-exponential model and the D, D*, and f parameters of the IVIM model were calculated separately for each TE. Repeat measures were assessed by calculating the coefficient of variation and Bland-Altman limits of agreement for each parameter. Spearman's rho test was used to analyse relationships between IVIM indices and TE. Our results showed that TE had an effect on IVIM quantification, which should be kept constant in the examination protocol at each individual institution. Alternatively, an extended IVIM could be used to eliminate the effect of the TE value on the quantitative parameters of IVIM. This may be helpful for guiding clinical research, especially for longitudinal studies.

Multi-model Analysis of Diffusion-weighted Imaging of Normal Testes at 3.0 T: Preliminary Findings.

RATIONALE AND OBJECTIVES: This study aimed to establish diffusion quantitative parameters (apparent diffusion coefficient [ADC], DDC, α, Dapp, and Kapp) in normal testes at 3.0 T. MATERIALS AND METHODS: Sixty-four healthy volunteers in two age groups (A: 10-39 years; B: ≥ 40 years) underwent diffusion-weighted imaging scanning at 3.0 T. ADC1000, ADC2000, ADC3000, DDC, α, Dapp, and Kapp were calculated using the mono-exponential, stretched-exponential, and kurtosis models. The correlations between parameters and the age were analyzed. The parameters were compared between the age groups and between the right and the left testes. RESULTS: The average ADC1000, ADC2000, ADC3000, DDC, α, Dapp, and Kapp values did not significantly differ between the right and the left testes (P > .05 for all). The following significant correlations were found: positive correlations between age and testicular ADC1000, ADC2000, ADC3000, DDC, and Dapp (r = 0.516, 0.518, 0.518, 0.521, and 0.516, respectively; P < .01 for all) and negative correlations between age and testicular α and Kapp (r = -0.363, -0.427, respectively; P < .01 for both). Compared to group B, in group A, ADC1000, ADC2000, ADC3000, DDC, and Dapp were significantly lower (P < .05 for all), but α and Kapp were significantly higher (P < .05 for both). CONCLUSIONS: Our study demonstrated the applicability of the testicular mono-exponential, stretched-exponential, and kurtosis models. Our results can help establish a baseline for the normal testicular parameters in these diffusion models. The contralateral normal testis can serve as a suitable reference for evaluating the abnormalities of the other side. The effect of age on these parameters requires further attention.