For our White Papers, please refer to the list below.
Safety Evaluation of Anti-Amyloid-β Antibodies in Alzheimer’s Disease – ARIA
This paper provides an overview of ARIA, including a summary of ARIA imaging evaluation in clinical trials related to anti-Aβ antibodies.
The Utilization Situation of Imaging Endpoints – An Imaging Endpoint List –
Over the past quarter-century, imaging endpoints have been used in many clinical trials for drug and medical device development. In this article, we analyze the use of imaging endpoints in each disease based on information from ClinicalTrials.gov, and summarize the imaging endpoints that are frequently used in each disease category.
The Methodology of Centralized Image Interpretation and Roles of an Imaging CRO: Centralized Image Interpretation Variations
We would like to introduce the types of central review according to their roles and characteristics when designing central review.
By defining the roles and objectives of central review in each clinical trial, the central review would be performed more efficiently and effectively. When objectives and roles are well defined, each step of the central review can be designed in detail.
The Methodology of Centralized Image Interpretation and Roles of an Imaging CRO: An Overview
In this article, we would like to provide an overview of central review.
Imaging central review should be properly designed to minimize bias and maximize the accuracy of clinical trial results, working with Imaging CROs as needed.
The Development of Software as a Medical Device (SaMD) -Clarification of Clinical Significance-
Clarification of clinical significance is very important in the development of SaMDs (Software as a Medical Device) that have become active in recent years.
This whitepaper summarizes the items that should be considered when clarifying the clinical significance based on the “Guidelines of Determining Whether Software is Classified as a Medical Device” issued by the Ministry of Health, Labour and Welfare (MHLW) of Japan in 2021.
Publication Notice Clinical Trials for Medical Imaging Diagnostic Decision Support Systems – The Social Implementation of Medical Artificial Intelligence -
In this article, we will introduce the overall picture of clinical trials of medical imaging support systems including AI-CAD. We hope that you will enjoy it.
Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 3 Clinical Significance of “Brain Volume Visualization”: A Treatment Strategy for Long-Term Prognosis
We would like to share the third article, the final article in the series by Dr. Kenzo Sakurai of St. Marianna University School of Medicine titled: “Clinical Significance of ‘Brain Volume Visualization’: A Treatment Strategy for Long-Term Prognosis” from the series “Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis.”
In this article, there is a discussion how to apply a brain imaging analysis program to actual clinical practice. We hope that you will enjoy it.
Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 2: The Usefulness in Multiple Sclerosis Treatment: Potential of Being a Part of a New Evaluation Scale
We would like to share the second article written by Dr. Kenzo Sakurai of St. Marianna University School of Medicine titled: “The Usefulness in Multiple Sclerosis Treatment: Potential of Being a Part of a New Evaluation Scale” from the series “Clinical Application of a Brain Image Analysis Programfor Multiple Sclerosis.”
In this second article, there is a discussion of the possibility of a new evaluation method based on an actual case in which brain volume was measured by a brain image analysis program. We hope that you will enjoy it.
Publication Notice Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis Part 1: Multiple Sclerosis and Diagnostic Imaging
In recent years, the pathogenesis of multiple sclerosis has become better understood, and new therapeutic agents have been developed one after another. In order to understand the pathogenesis of multiple sclerosis, it is important to measure brain volume and lesion volume.
Dr. Kenzo Sakurai, St. Marianna University School of Medicine, has written a three part series of articles on the significance of brain volume measurement using a brain image analysis program, titled “Clinical Application of a Brain Image Analysis Program for Multiple Sclerosis.”
We are pleased to share the first article from the series titled “Multiple Sclerosis and Diagnostic Imaging.” We hope that you will enjoy it.
Kobe Cardiovascular Core Laboratory – Introduction on the Service for Clinical Trials Using Intravascular Imaging Endpoints
In 2012, researchers from the cardiology department of Kobe University and Microns have established Kobe Cardiovascular Core Laboratory (KCCL). Since then, KCCL has been conducting independent intravascular analysis for coronary imaging technologies, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT). KCCL has accomplished over thousands of analysis cases. In this white paper, we introduce KCCL’s performance as well as their unique quality control system.
iRECIST Overview
This time, we’d like to introduce you iRECIST. This criteria has been announced by the RECIST working group of the EORTC (European Agency for Research and Treatment of Cancer) in 2017.
Immunotherapy has been trends in oncological treatment. iRECIST describes how to measure and assess tumor size in immunotherapy clinical trials. We summarized the outline of this guideline here.
Clinical Evaluation of AI medical image diagnostic software: The Importance of the Reference Standards
We’re pleased to announce that we will finaly issue our white paper, Micron’s ViewPoint for our English web site. We’re going to introduce you the latest trends of the medical imaging in the clinical trial. We appreciate we can show you our experiences and abilities in medical imagings.
Recent advances in AI technology have led to the development of a computer detection and diagnostic support systems equipped with AI in the field of image diagnosis. However, there are many challenges to the social implementation of CAD with AI, such as image data collection, clinical trials, and regulatory approval.
This time, we introduce the creation of reference standards for clinical trials of of intelligence decision support systems for diagnosis based on medical imaging , including CAD with AI.