Drug Discovery Research

04:47 EDT 16th August 2018 | BioPortfolio



The accurate diagnosis of thyroid follicular/Hürthle cell tumors is challenging and a matter of controversy. We present a series of patients in whom a misclassification of follicular/Hürthle cell thyroid lesions as benign has led to devastating clinical outcomes.




Endocrine tumor markers (ETMs) are important and indispensable tools in the diagnosis and follow-up of endocrine tumors. Unexpectedly high level of ETM (UHLETM) is often encountered in clinical practice. The objectives of this article are to discuss the approach to UHLETMs and describe the most common UHLETMs.

First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial.

Purpose To assess pertuzumab plus trastuzumab and an aromatase inhibitor (AI) in patients with human epidermal growth factor receptor 2 (HER2)-positive and hormone receptor-positive metastatic/locally advanced breast cancer (MBC/LABC). Patients and Methods The PERTAIN trial (NCT01491737) is an ongoing randomized, open-label, multicenter-80 sites and eight countries-phase II trial. Patients have HE...

Randomized Trial of Hypofractionated, Dose-Escalated, Intensity-Modulated Radiation Therapy (IMRT) Versus Conventionally Fractionated IMRT for Localized Prostate Cancer.

Purpose Hypofractionated radiotherapy delivers larger daily doses of radiation and may increase the biologically effective dose delivered to the prostate. We conducted a randomized trial testing the hypothesis that dose-escalated, moderately hypofractionated intensity-modulated radiation therapy (HIMRT) improves prostate cancer control compared with conventionally fractionated IMRT (CIMRT) for men...

Tumor Mutation Burden as a Biomarker in Resected Non-Small-Cell Lung Cancer.

Purpose The survival benefit with adjuvant chemotherapy for patients with resected stage II-III non-small-cell lung cancer (NSCLC) is modest. Efforts to develop prognostic or predictive biomarkers in these patients have not yielded clinically useful tests. We report findings from the Lung Adjuvant Cisplatin Evaluation (LACE)-Bio-II study, in which we analyzed next-generation sequencing and long-te...

21 Century Citizen Pharma: The FDA & Patient-Focused Product Development.

Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration ("FDA"). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation ov...

Real-World Evidence in the Real World: Beyond the FDA.

The 21 Century Cures Act ("Cures Act") relies on the concept of real-world evidence ("RWE") to improve the Food and Drug Administration ("FDA") approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits. But we also ca...

The Challenge of Regulating Clinical Decision Support Software After 21 Century Cures.

Real-World Data Analytics Fit for Regulatory Decision-Making.

Healthcare database analyses (claims, electronic health records) have been identified by various regulatory initiatives, including the 21 Century Cures Act and Prescription Drug User Fee Act ("PDUFA"), as useful supplements to randomized clinical trials to generate evidence on the effectiveness, harm, and value of medical products in routine care. Specific applications include accelerated drug app...

Practice-Based Research Networks and the Mandate for Real-World Evidence.

The 21 Century Cures Act encourages the Food and Drug Administration to consider "real-world evidence" in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority...

Sensitivity and Specificity Estimation using Patient-Specific Microwave Imaging in Diverse Experimental Breast Phantoms.

Many new clinical investigations of microwave breast imaging have been published in recent years. Trials with over one hundred participants have indicated the potential of microwave imaging to detect breast cancer, with particularly encouraging sensitivity results reported from women with dense breasts. The next phase of clinical trials will involve larger and more diverse populations, including w...

FissureNet: A Deep Learning Approach For Pulmonary Fissure Detection in CT Images.

Pulmonary fissure detection in computed tomography (CT) is a critical component for automatic lobar segmentation. The majority of fissure detection methods use feature descriptors that are hand-crafted, low-level, and have local spatial extent. The design of such feature detectors is typically targeted towards normal fissure anatomy, yielding low sensitivity to weak and abnormal fissures that are ...

Mechanical Anisotropy Assessment in Kidney Cortex Using ARFI Peak Displacement: Preclinical Validation and Pilot In Vivo Clinical Results in Kidney Allografts.

The kidney is an anisotropic organ, with higher elasticity along versus across nephrons. The degree of mechanical anisotropy in the kidney may be diagnostically relevant if properly exploited; however, if improperly controlled, anisotropy may confound stiffness measurements. The purpose of this study is to demonstrate the clinical feasibility of Acoustic Radiation Force (ARF) induced peak displace...

Dual-layer Strengthened Collaborative Topic Regression Modeling for Predicting Drug Sensitivity.

An effective way to facilitate the development of modern oncology precision medicine is the systematical analysis of the known drug sensitivities that have emerged in recent years. Meanwhile, the screening of drug response in cancer cell lines provides an estimable genomic and pharmacological data towards high accuracy prediction. Existing works primarily utilize genomic or functional genomic feat...

Clinical Decision Support Tools Need to Improve More Than Just Process Outcomes.

Transient Elastography for Monitoring for Hepatotoxicity in Rheumatoid Arthritis Patients on Long-term Methotrexate.

Relapsing Polychondritis Manifesting as Tracheal and Costochondral Inflammation on Magnetic Resonance Imaging.

Acute Management of Optic Neuritis: An Evolving Paradigm.

The current management of acute optic neuritis (ON) is focused on expediting visual recovery through the use of high-dose intravenous corticosteroids. The recent identification of specific autoantibodies associated with central nervous system inflammatory disorders has provided novel insights into immune targets and mechanisms that impact the prognosis, treatment, and recurrence of ON. Therefore, ...

In Memoriam: Sheldon Baum 1927-2018: Erratum.

Re: Response Assessment of 223Ra Treatment: Should a Fluorocholine PET/CT Be Performed?

Demonstration of Tubercular "Abdominal Cocoon" (Sclerosing Encapsulating Peritonitis) in 18F-FDG PET/CT.

Sclerosing encapsulating peritonitis also called as abdominal cocoon is a less understood condition mostly due to idiopathic causes and sometimes secondary to tuberculosis or peritoneal dialysis. This report describes the typical features of "abdominal cocoon" on F-FDG PET/CT in a young woman, which was later diagnosed to be secondary to tuberculosis. Because the early features of this unusual ent...

99mTc-MDP Bone Scan and 18F-FDG PET/CT Imaging of Multiple Extraskeletal Osteosarcomas.

Extraskeletal osteosarcomas are uncommon entities in clinical practice, which account for 1% to 2% of all soft tissue sarcomas. We here reported a case of multiple extraskeletal osteosarcomas and nuclear medicine imaging findings of this disease in Tc-MDP bone scan as well as F-FDG PET/CT.

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