scholarly journals Guidance on the use of PET for treatment planning in radiotherapy clinical trials

2019 ◽  
Vol 92 (1103) ◽  
pp. 20190180
Author(s):  
Lucy C Pike ◽  
Christopher M Thomas ◽  
Teresa Guerrero-Urbano ◽  
Andriana Michaelidou ◽  
Tony Greener ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Quality Assurance ◽  
Research Network ◽  
Sufficient Information ◽  
Design Data ◽  
Imaging Protocol ◽  
Positron Emission ◽  
National Cancer Research Institute ◽  
Resource Requirements ◽  
High Level

The aim of this article is to propose meaningful guidance covering the practical and technical issues involved when planning or conducting clinical trials involving positron emission tomography (PET)-guided radiotherapy. The complexity of imaging requirements will depend on the study aims, design and PET methods used. Where PET is used to adapt radiotherapy, a high level of accuracy and reproducibility is required to ensure effective and safe treatment delivery. The guidance in this document is intended to assist researchers designing clinical trials involving PET-guided radiotherapy to provide sufficient information about the appropriate methods to complete PET-CT imaging to a consistent standard at participating centres. The guidance is divided into six categories: application of PET in radiotherapy, resource requirements, quality assurance, imaging protocol design, data management and image processing. Each section provides an overview of the recent literature to support the specific recommendations. This guidance builds on previous recommendations from the National Cancer Research Institute PET Research Network and has been produced in collaboration with the National Radiotherapy Trials Quality Assurance Group.

scholarly journals Guidance on the use of MRI for treatment planning in radiotherapy clinical trials

2020 ◽  
Vol 93 (1105) ◽  
pp. 20190161
Author(s):  
Robert I Johnstone ◽  
Teresa Guerrero-Urbano ◽  
Andriana Michaelidou ◽  
Tony Greener ◽  
Elizabeth Miles ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Quality Assurance ◽  
Treatment Planning ◽  
Sufficient Information ◽  
Planning Systems ◽  
Imaging Guidance ◽  
Safety Issues ◽  
Treatment Planning Systems ◽  
Trial Protocols

The aim of this article is to propose meaningful guidance covering the technical and safety issues involved when designing or conducting radiotherapy clinical trials that use MRI for treatment planning. The complexity of imaging requirements will depend on the trial aims, design and MRI methods used. The use of MRI within the RT pathway is becoming more prevalent and clinically appropriate as access to MRI increases, treatment planning systems become more versatile and potential indications for MRI-planning in RT are documented. Novel MRI-planning opportunities are often initiated and validated within clinical trials. The guidance in this document is intended to assist researchers designing RT clinical trials involving MRI, so that they may provide sufficient information about the appropriate methods to be used for image acquisition, post-processing and quality assurance such that participating sites complete MRI to consistent standards. It has been produced in collaboration with the National Radiotherapy Trials Quality Assurance Group (RTTQA). As the use of MRI in RT is developed, it is highly recommended for researchers writing clinical trial protocols to include imaging guidance as part of their clinical trial documentation covering the trial-specific requirements for MRI procedures. Many of the considerations and recommendations in this guidance may well apply to MR-guided treatment machines, where clinical trials will be crucial. Similarly, many of these recommendations will apply to the general use of MRI in RT, outside of clinical trials. This document contains a large number of recommendations, not all of which will be relevant to any particular trial. Designers of RT clinical trials must therefore take this into account. They must also use their own judgement as to the appropriate compromise between accessibility of the trial and its technical rigour.

scholarly journals A Research on Landslides Automatic Extraction Model Based on the Improved Mask R-CNN

2021 ◽  
Vol 10 (3) ◽  
pp. 168
Author(s):  
Peng Liu ◽  
Yongming Wei ◽  
Qinjun Wang ◽  
Jingjing Xie ◽  
Yu Chen ◽  
...  
Keyword(s):  
Remote Sensing Data ◽  
Extraction Methods ◽  
New Method ◽  
Detection Accuracy ◽  
Sufficient Information ◽  
Automatic Extraction ◽  
Emergency Rescue ◽  
Feature Pyramid ◽  
High Level ◽  
Extraction Model

Landslides are the most common and destructive secondary geological hazards caused by earthquakes. It is difficult to extract landslides automatically based on remote sensing data, which is import for the scenario of disaster emergency rescue. The literature review showed that the current landslides extraction methods mostly depend on expert interpretation which was low automation and thus was unable to provide sufficient information for earthquake rescue in time. To solve the above problem, an end-to-end improved Mask R-CNN model was proposed. The main innovations of this paper were (1) replacing the feature extraction layer with an effective ResNeXt module to extract the landslides. (2) Increasing the bottom-up channel in the feature pyramid network to make full use of low-level positioning and high-level semantic information. (3) Adding edge losses to the loss function to improve the accuracy of the landslide boundary detection accuracy. At the end of this paper, Jiuzhaigou County, Sichuan Province, was used as the study area to evaluate the new model. Results showed that the new method had a precision of 95.8%, a recall of 93.1%, and an overall accuracy (OA) of 94.7%. Compared with the traditional Mask R-CNN model, they have been significantly improved by 13.9%, 13.4%, and 9.9%, respectively. It was proved that the new method was effective in the landslides automatic extraction.

scholarly journals A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Care Professionals ◽  
Digital Health ◽  
Disease Status ◽  
Proximal Femoral Fracture ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Physical Mobility ◽  
High Level

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

scholarly journals Complete heart block in cardiac sarcoidosis reversed by corticosteroid therapy: time course of resolution

2021 ◽  
Vol 14 (3) ◽  
pp. e240834
Author(s):  
Anna Tomdio ◽  
Huzaefah Syed ◽  
Kenneth Ellenbogen ◽  
Jordana Kron
Keyword(s):  
Heart Block ◽  
Time Course ◽  
Cardiac Sarcoidosis ◽  
Complete Heart Block ◽  
Positron Emission ◽  
Av Conduction ◽  
Magnetic Resonance Imaging Mri ◽  
High Level ◽  
Active Inflammation ◽  
Lateral Walls

A 53-year-old man was admitted for recurrent syncope and found to have complete heart block (CHB). Cardiac magnetic resonance imaging MRI) showed extensive patchy late gadolinium enhancement in the apical and lateral walls, consistent with cardiac sarcoidosis (CS) but no scar in the septum. A fluorodeoxyglucose (FDG)–positron emission tomography showed FDG uptake in the septum and basal lateral walls. Imaging suggested active inflammation in the septum affecting atrioventricular (AV) conduction but no irreversible fibrosis. Diagnosis of isolated CS requires a high level of suspicion and multidisciplinary teamwork involving heart failure specialists, electrophysiologists and rheumatologists. After specialist and patient discussion, treatment of the disease was initiated with prednisone 40 mg daily, 11 months after presenting with CHB. Three weeks later, ECG with pacing inhibited showed second-degree AV block Mobitz type II and 4 weeks later, AV conduction recovery. This highlights the importance of immediate therapy in reversing AV conduction abnormalities in CS.

Quality Assurance and Cardiopulmonary Exercise Testing in Clinical Trials

2008 ◽  
Vol 14 (4) ◽  
pp. 283-289 ◽  
Author(s):  
Clinton A. Brawner ◽  
Jonathan K. Ehrman ◽  
Heather Aldred ◽  
John R. Schairer ◽  
Steven J. Keteyian
Keyword(s):  
Clinical Trials ◽  
Quality Assurance ◽  
Exercise Testing ◽  
Cardiopulmonary Exercise Testing ◽  
Cardiopulmonary Exercise

scholarly journals Implementation of and experiences with new automation

2000 ◽  
Vol 22 (6) ◽  
pp. 199-202 ◽  
Author(s):  
Ifte Mahmud ◽  
David Kim
Keyword(s):  
Quality Assurance ◽  
Implementation Process ◽  
Regulatory Compliance ◽  
Contributing Factors ◽  
The Future ◽  
Industry Automation ◽  
High Level ◽  
Automation Technology ◽  
And Robotics ◽  
Testing Group

In an environment where cost, timeliness, and quality drives the business, it is essential to look for answers in technology where these challenges can be met. In the Novartis Pharmaceutical Quality Assurance Department, automation and robotics have become just the tools to meet these challenges. Although automation is a relatively new concept in our department, we have fully embraced it within just a few years. As our company went through a merger, there was a significant reduction in the workforce within the Quality Assurance Department through voluntary and involuntary separations. However the workload remained constant or in some cases actually increased. So even with reduction in laboratory personnel, we were challenged internally and from the headquarters in Basle to improve productivity while maintaining integrity in quality testing. Benchmark studies indicated the Suffern site to be the choice manufacturing site above other facilities. This is attributed to the Suffern facility employees' commitment to reduce cycle time, improve efficiency, and maintain high level of regulatory compliance. One of the stronger contributing factors was automation technology in the laboratoriess, and this technology will continue to help the site's status in the future. The Automation Group was originally formed about 2 years ago to meet the demands of high quality assurance testing throughput needs and to bring our testing group up to standard with the industry. Automation began with only two people in the group and now we have three people who are the next generation automation scientists. Even with such a small staff,we have made great strides in laboratory automation as we have worked extensively with each piece of equipment brought in. The implementation process of each project was often difficult because the second generation automation group came from the laboratory and without much automation experience. However, with the involvement from the users at ‘get-go’, we were able to successfully bring in many automation technologies. Our first experience with automation was SFA/SDAS, and then Zymark TPWII followed by Zymark Multi-dose. The future of product testing lies in automation, and we shall continue to explore the possibilities of improving the testing methodologies so that the chemists will be less burdened with repetitive and mundane daily tasks and be more focused on bringing quality into our products.

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