Anushya Vijayananthan

The importance of Good Clinical Practice guidelines and its role in clinical trials.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

Differentiation between benign and malignant breast lesions using quantitative diffusion-weighted sequence on 3 T MRI

AIM To investigate the capability and diagnostic accuracy of diffusion-weighted imaging (DWI) in differentiating benign from malignant breast lesions using 3 T magnetic resonance imaging (MRI). MATERIALS AND METHODS Women with suspicious or indeterminate breast lesions detected at MRI, mammogram and/or ultrasound were recruited for dynamic contrast-enhanced (DCE)-MRI and DWI prior to their biopsy. Image fusion of DCE-MRI with apparent diffusion coefficient (ADC) map was utilized to select the region of interest (ROI) for ADC calculation in the area that showed the most avid enhancement. DWI was performed using two sets of b-values at 500 and 1000 s/mm(2), respectively. RESULTS Fifty women were recruited and the final analysis comprised 44 breast lesions, 31 of which were malignant and 13 were benign. Significant results were obtained between ADC values of benign and malignant lesions (p < 0.001). The cut-off ADC values for benign and malignant lesions were 1.21 × 10(-3) mm(2)/s for b = 500 s/mm(2) and 1.22 × 10(-3) mm(2)/s for b = 1000 s/mm(2), respectively. The sensitivity of DCE-MRI alone was 100% with a specificity of 66.7%. When DCE-MRI was combined with b = 1000 s/mm(2), the specificity rose to 100%, while only mildly affecting sensitivity (90.6%). No significant correlation was found between ADC values and prognostic factors, such as lymph node metastasis, tumour size, oestrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) status, and tumour grades. CONCLUSION The present study provides consistent evidence to support DWI as a diagnostic tool for breast lesion characterization. A combination of DCE-MRI with DWI is suggested to improve the sensitivity and specificity of lesion characterization.

Non‐alcoholic fatty liver disease in diabetics – prevalence and predictive factors in a multiracial hospital clinic population in Malaysia

There is currently no published study comparing prevalence of non‐alcoholic fatty liver disease (NAFLD) and associated factors among diabetics of different ethnicity in the Asia‐Pacific region.

The transjugular intrahepatic portosystemic shunt (TIPS)

The creation of an intrahepatic portosystemic shunt via a transjugular approach (TIPS) is an interventional radiological procedure used to treat the complications of portal hypertension. TIPS insertion is principally indicated to prevent or arrest variceal bleeding when medical or endoscopic treatments fail, and in the management refractory ascites. This review discusses the development and execution of the technique, with focus on its clinical efficacy. Patient selection, imaging surveillance, revision techniques, and complications are also discussed.

Automated characterization of fatty liver disease and cirrhosis using curvelet transform and entropy features extracted from ultrasound images

Fatty liver disease (FLD) is reversible disease and can be treated, if it is identified at an early stage. However, if diagnosed at the later stage, it can progress to an advanced liver disease such as cirrhosis which may ultimately lead to death. Therefore, it is essential to detect it at an early stage before the disease progresses to an irreversible stage. Several non-invasive computer-aided techniques are proposed to assist in the early detection of FLD and cirrhosis using ultrasound images. In this work, we are proposing an algorithm to discriminate automatically the normal, FLD and cirrhosis ultrasound images using curvelet transform (CT) method. Higher order spectra (HOS) bispectrum, HOS phase, fuzzy, Kapoor, max, Renyi, Shannon, Vajda and Yager entropies are extracted from CT coefficients. These extracted features are subjected to locality sensitive discriminant analysis (LSDA) feature reduction method. Then these LSDA coefficients ranked based on F-value are fed to different classifiers to choose the best performing classifier using minimum number of features. Our proposed technique can characterize normal, FLD and cirrhosis using probabilistic neural network (PNN) classifier with an accuracy of 97.33%, specificity of 100.00% and sensitivity of 96.00% using only six features. In addition, these chosen features are used to develop a liver disease index (LDI) to differentiate the normal, FLD and cirrhosis classes using a single number. This can significantly help the radiologists to discriminate FLD and cirrhosis in their routine liver screening.

Decision support system for fatty liver disease using GIST descriptors extracted from ultrasound images

Steatosis or fatty liver disease (FLD) is characterized by the abnormal retention of large vacuoles of neutral fat in the liver cells, either due to alcoholism or metabolic syndrome. Succession of FLD can lead to severe liver diseases such as hepatocellular carcinoma, cirrhosis and hepatic inflammation but it is a reversible disease if diagnosed early. Thus, computer-aided diagnostic tools play a very important role in the automated diagnosis of FLD. This paper focuses on the detection of steatosis and classification of steatotic livers from the normal using ultrasound images. The significant information from the image is extracted using GIST descriptor models. Marginal Fisher Analysis (MFA) integrated with Wilcoxon signed-rank test helps to eliminate the trivial features and provides the distinctive features for qualitative classification. Finally the clinically significant features are fused using classifiers such as decision tree (DT), support vector machine (SVM), adaBoost, k-nearest neighbor (kNN), probabilistic neural network (PNN), naive Bayes (NB), fuzzy Sugeno (FS), linear and quadratic discriminant analysis classification of normal and abnormal liver images. Results portray that PNN classifier can diagnose FLD with an average classification accuracy of 98%, 96% sensitivity, 100% specificity and Area Under Curve (AUC) of 0.9674 correctly.

Shearwave Elastography Increases Diagnostic Accuracy in Characterization of Breast Lesions.

AbstractThe purpose of this study was to investigate the diagnostic efficacy of shearwave elastography (SWE) in differentiating between benign and malignant breast lesions.One hundred and fifty-nine lesions were assessed using B-mode ultrasound (US) and SWE parameters were recorded (Emax, Emean, Emin, Eratio, SD). SWE measurements were then correlated with histopathological diagnosis.The final sample contained 85 benign and 74 malignant lesions. The maximum stiffness (Emax) with a cutoff point of ≥ 56.0 kPa (based on ROC curves) provided sensitivity of 100.0%, specificity of 97.6%, positive predictive value (PPV) of 97.4%, and negative predictive value (NPV) of 100% in detecting malignant lesions. A cutoff of ≥80 kPa managed to downgrade 95.5% of the Breast Imaging-Reporting and Data System (BI-RADS) 4a lesions to BI-RADS 3, negating the need for biopsy. Using a combination of BI-RADS and SWE, the authors managed to improve the PPV from 2.3% to 50% in BI-RADS 4a lesions.SWE of the breast provides highly specific and sensitive quantitative values that are beneficial in the characterization of breast lesions. Our results showed that Emax is the most accurate value for differentiating benign from malignant lesions.

Benign Teratoma of the Liver: A rare cause of cholangitis.

Teratomas are neoplasms characterised by an abnormal growth of tissues derived from the three germinal layers. The term ‘teratoma’ is derived from the Greek root ‘teratos’, meaning monster. Germ cells develop in the embryo and subsequently become the cells that make up the reproductive system. During fetal development, these cells follow a midline path and descend into the pelvis as ovarian cells or the scrotal sac as testicular cells. The presence of germ cells in extragonadal sites is because of the failure of these cells to migrate along the urogenital ridge. Therefore, teratomas occur in order of decreasing frequency in the ovaries, testes, anterior mediastinum, retroperitoneum, sacrococcygeal region and cranium. Liver teratomas are very rare; of the 25 hepatic teratomas described in the literature, only five have occurred in adults. The majority of the cases were in female children below the age of three, mostly arising in the right lobe of liver. We report a case of an adult male with benign mature teratoma arising in the left lobe of liver, compressing the common bile duct and causing obstructive jaundice.

Transarterial embolisation of hepatocellular carcinoma with doxorubicin-eluting beads: single centre early experience

Purpose: This is a retrospective study to evaluate the results of our early experience of using doxorubicin eluting beads (DEB) to treat patients with early and intermediate hepatocellular carcinoma (HCC). Material and methods: A cohort of 19 patients (84.2% male; 15.8% female; mean age 59.2 years ± 11.0; range, 32-80 years) with documented HCC of size 1.8-10cm (mean, 4.0cm ± 1.8 ) undergoing DEB transarterial chembolisation (TACE) was reviewed. All patients had at least one image examination (multiphase computed tomography or magnetic resonance imaging) after embolisation. Results: A total of 32 procedures were performed. The objective response according to the European Association for the Study of the Liver criteria was 57.9% at 1-month, 42.8% at 6-month and 50.0% at 1-year follow up. There were 4 (21.1%) treatment-related complications (1 liver abscess, 2 pancreatitis and 1 tumour rupture) which resulted in 2 deaths. One death occurred 3 weeks after second embolisation, due to ruptured pancreatic pseudocyst, giving a 5.3% 30-day mortality rate. Another patient died 2 months after embolisation caused by tumour rupture. Eight patients received radiofrequency ablation after embolisation for residual or recurrent tumours. The 1-year survival rate in the DEB TACE only group was 80% while the 1- and 2-year survival rate in the group that received radiofrequency after DEB TACE was 85.7% and 100% respectively. Conclusion: DEB TACE is safe and effective in select group of patients. Survival may be improved when combined with other treatment modality.

Malignant ovarian mixed germ cell tumour: a rare combination.

Ovarian germ cell tumours are very rare and affect mainly young girls and women. Due to this, the conservation of reproductive potential is of great concern. One of the most remarkable advances in oncology is in the treatment of malignant ovarian germ cell tumours. Two histological groups are distinguished: dygerminomas, equivalent to testicular seminomas, and non-dysgerminomatous tumours. We report a case of a 30-year-old nulliparous woman who presented with persistent per vaginal bleeding and was found to have a malignant mixed germ cell tumour comprising of both embryonal carcinoma and choriocarcinoma.