Distributed Intelligent Ultrasound Imaging System for Secure in-community Diagnostics (SecureUltrasound)

Lead Research Organisation: Cranfield University
Department Name: Sch of Aerospace, Transport & Manufact

Abstract

The proposed research is going to develop low cost, secure, point of care ultrasound imaging for prenatal care for India. The availability of skilled technician or doctor that can conduct ultrasound scanning for pregnant mothers in remote areas is a major challenge in India. Usage of diagnostics ultrasound in India has also been controversial because of its extensive misuse for sex-selective abortions. Indian government introduced legislation back in 1994 to ban the disclosure of foetus gender through the PC-PNDT (Pre-Conception and Prenatal Diagnostic Techniques) Act and continuously tightened regulation to limit such misuse, these efforts have had limited or no effect on the ground. The nature and scale of the problem is unique to India. A secure ultrasound scanning system with guided image capture and a remote diagnostic service, that can work in rural areas in India, is essential to significantly improve the prenatal care, health assessment and wellbeing for the baby and the mother. The Indian challenge is also valid in other Low and Middle Income Countries (LMICs) on the OECD DAC list of ODA recipients, such as African states.

The proposed research builds on state of the art freehand 3D ultrasound technology, care pathway modelling and design, cloud based framework for ultrasound image analysis, servitization of the healthcare provision and augmented reality based digital medical assistant for prenatal scanning. This research will build on the existing research and investigate new technology development to address the 'skills shortage' and 'selective abortion' challenges in India during prenatal care. The research will bring the best universities and research institutes in India to work directly with Cranfield University to solve this social challenge using latest technologies.

This research will build capability and capacity in less-skilled ultrasound scanning for prenatal care with no visual feedback during scanning in India. The research will start with a two weeks long stakeholder interaction in India and intensive literature review. The interaction will involve direct prenatal care observation in unstructured rural areas, rural healthcare centres, semi-urban municipality areas, urban deprived areas and modern hospitals as per the ethical guidelines of India. A shorter interaction will take place with three surgeries and three hospitals in the UK. Engaging with the end user to better understand their expectations and requirements will be a major focus of this part of the research. The requirements will be the basis for the ultrasound scanning system development, starting with a concept design. The system will have two major components: the ultrasound transmit and receive system with customised ultrasound transducer and the AR based data capture assistant. Working prototypes of the technologies will be built for controlled clinical validations. During the research across the two countries, ethical guidelines and processes will be implemented in a systematic manner in compliance with the requirements from Cranfield University, IISc, SJRI and NIAS. The research will address the cultural and social sensitivities of the participating communities. This will have direct impact on the user interaction, data capture, transmission and storage. New technologies developed will be tested in laboratory conditions first and then in SJRI within a controlled clinical environment. The new ultrasound hardware and software performance will be compared to the best quality ultrasound scanners available in the commercial market. In parallel, the impact of the secure ultrasound scanning service for mothers across different communities will be studied using a combination of quantitative and qualitative methods. The impact of the novel technologies on the Indian society will be studied in detail by NIAS. the research team will engage with the manufacturers and their supply chain to further exploit the results of this research.

Planned Impact

The SecureUltrasound research will impact people, knowledge, economy and the society as follows:

Impacting people:
The proposed research is going to develop low cost, secure, point of care ultrasound imaging for prenatal care for India. Ultrasound is a safe and cost effective medical diagnostic technology used around the world for multiple medical conditions including prenatal care. The availability of skilled technician or doctor that can conduct ultrasound scanning for pregnant mothers in remote areas is a major and unique challenge in India. Usage of diagnostics ultrasound in India has also been controversial because of its extensive misuse for sex-selective abortions. This research will develop novel technologies to address these challenges in India. The project will enable the widespread and safe use of ultrasound scanning for prenatal care across India. This research will have a secondary impact on the UK by helping to provide ultrasound scanning for prenatal care at the surgery level. Both countries will improve antenatal care and reduce perinatal morbidity and mortality rates. Each researcher will be supported through several researcher development programmes and research staff development conferences across the partner organisations. Cranfield University has EU recognition for HR Excellence in Research. Entrepreneurship of the researchers will be encouraged through Cranfield Venture Day and through training on commercialisation at IISc. The staff development will enhance the career prospect of the research team and will significantly support their international profile development in research.

Impacting knowledge:
There are two areas of fundamental knowledge development: use of MEMS based sensors with the 2D ultrasound scanners to develop 3D images without any visual guidance; and the skin contact detector and the foetal motion detection for ultrasound data capture assistance. The research will develop new knowledge in using the inertial information to spatially locate 2D images and their relationships with other images. The data capture assistance must consider different skin conditions and maturity of the pregnancy and understand the complex relationships between the biological parameters, the movement of the transducer with the quality of the currently acceptable ultrasound scans i.e. 3MHz centre frequency and about 100% bandwidth. The research will also develop new knowledge in overlaying of a dynamically adjusted grid and movement advice on the mother during the data capture. The adjustment will cover size and shape of the body and the quality of the transducer movement. Implicit knowledge on the prenatal screening of babies and mother health assessment will be made explicit through a structured knowledge capture process.

Impacting economy:
The research will impact significantly on the Indian economy by making ultrasound scanning more accessible and popular across India. Millions of more people in rural areas would be able to access the service despite a lack of skilled technicians in the areas. During the project, a commercialisation route will be agreed amongst the participating organisations. Professor Arora will identify manufacturers in India that will exploit the technologies developed in the research. The team in the UK will be engaged with the NHS to explore further exploitation of the service at the surgery level.

Impacting the Society:
The research team will impact society through direct intervention and by addressing a unique societal challenge in India. 1. The research will stop parents discriminating against female foetuses. The research will allow much more people in India to access the benefits of ultrasound scanning during pregnancy. This will significantly improve antenatal care and reduce perinatal morbidity and mortality rates across India. The research will improve the boy-girl ratio in the country over time.

Publications

10 25 50
 
Description There have been three major research outcomes this year:
- we are now able to analyse the image quality of ultrasound data acquisition and to distribute that data to those in remote locations using the cloud
- we are now able to utilise sensors to track the location of the transducer and capture its motion. We can also share that data with other data analysis and visualisation software
- we are now able to correlate information about the location transducer, the grade of image acquisition quality, and visual feedback through augmented reality

In the previous year we had developed a novel approach for image-reconstruction when collecting data from ultrasound scanning. We have also integrated that in to our system with benefits realised in enhancing the image quality gathered.
Exploitation Route Further in-field, patient linked studies could be undertaken to explore the benefits of the proposed approaches.
The developed methods can be used for NDT (e.g. thermography) based studies to determine the health of components.
Sectors Aerospace, Defence and Marine,Digital/Communication/Information Technologies (including Software),Healthcare,Manufacturing, including Industrial Biotechology

 
Description The project has numerous cultural and ethical implications. Through this project, we have been able to open up conversations about the value and implications of hiding the gender information of babies. Based on engagement with medical experts and patients, we have been able to collate information about how they perceive the information that can be communicated in rural and urban settings. We will conduct further research to understand whether the patients and the medical experts trust the communicated information. We have also found initial results that can aid policy makers in respect to how data can be collected and distributed within the context of ultrasound scanning.
First Year Of Impact 2020
Sector Healthcare
Impact Types Cultural,Societal,Policy & public services

 
Title Estimation of Motion Parameters for Ultrasound Images Using Motion Blur Invariants 
Description The quality of fetal ultrasound images is significantly affected by motion blur while the imaging system requires low motion quality in order to capture accurate data. This can be achieved with a mathematical model of motion blur in time or frequency domain. We propose a new model of linear motion blur in both frequency and moment domain to analyse the invariant features of blur convolution for ultrasound images. Moreover, the model also helps to provide an estimation of motion parameters for blur length and angle. These outcomes might imply great potential of this invariant method in ultrasound imaging application. 
Type Of Material Improvements to research infrastructure 
Year Produced 2020 
Provided To Others? Yes  
Impact We have been able to characterise the image acquisition quality. 
URL https://arxiv.org/abs/2009.11117
 
Title Filter-generating system of Zernike polynomials 
Description This work proposes a new approach to find the generating function (GF) of the Zernike polynomials in two dimensional form. Combining the methods of GFs and discrete-time systems, we can develop two dimensional digital systems for systematic generation of entire orders of Zernike polynomials. We establish two different formulas for the GF of the radial Zernike polynomials based on both the degree and the azimuthal order of the radial polynomials. In this paper, we use four terms recurrence relation instead of the ordinary three terms recursion to calculate the radial Zernike polynomials and their GFs using unilateral 2D Z-transform. A spatio-temporal implementation scheme is developed for generation of the radial Zernike polynomials. The case study shows a reliable way to evaluate Zernike polynomials with arbitrary degrees and azimuthal orders. 
Type Of Material Improvements to research infrastructure 
Year Produced 2019 
Provided To Others? Yes  
Impact This provided a novel mechanism to evaluate images. 
URL https://dspace.lib.cranfield.ac.uk/handle/1826/14420
 
Title Image Quality Assessment (IQA) using image metrics called BRISQUE/PIQE/NIQE/SSIM 
Description These image metrics can help us to measure the image quality of ultrasound images for the purpose of this project. In this research, the IQA model is based on a highly competitive No Reference - IQA (NR - IQA) model called Blind/Referenceless Image Spatial Quality Evaluator (BRISQUE) initially designed for natural images were modified to evaluate structural ultrasound images. The BRISQUE model measures the image quality by using the locally normalized luminance coefficients, which were used to calculate the image features. The modified-BRISQUE model trained a new regression model using ultrasound image features and Difference Mean Opinion Score (DMOS) from a dataset of ultrasound images. 
Type Of Material Data analysis technique 
Year Produced 2019 
Provided To Others? No  
Impact Two types of benchmarks: objective and subjective assessments can be used as performance evaluators for both original and modified-BRISQUE models. There was a high correlation between the modified-BRISQUE with both benchmarks, and they were higher than those for the original BRISQUE. There is a significant percentage improvement in their correlation values. The modified-BRISQUE is statistically better than the original BRISQUE. The modified-BRISQUE model can accurately measure the image quality of ultrasound images. It is a practical NR-IQA model for ultrasound images without using reference images. 
 
Title Scan-line based 3D ultrasound reconstruction 
Description A method to analyse speed of sensor-based ultrasound data acquisition and a model to correct for imperfections in reconstructed volume due to fast probe-motion by accurate non-planar scan-line placements. 
Type Of Material Computer model/algorithm 
Year Produced 2021 
Provided To Others? Yes  
Impact Improved 2D quantification of re-sliced image from reconstructed volume. 
 
Description Clinical Feasibility of Secure Ultrasound sytem 
Organisation National Institute of Advanced Studies
Country India 
Sector Academic/University 
PI Contribution Preparation of documents (device specification, List of Equipment, instruments and test protocols) and submission for Institutional Ethics Committee (IEC) and regulatory government body to obtain permission to conduct clinical investigation.
Collaborator Contribution Approval from Institutional Ethics Committee of St John's to conduct clinical investigation. Central Drugs Standard Control Organisation (CDSCO) communicated to National Institute of Advanced Studies (NIAS) that the device for feasibility testing is considered equivalent to an ultrasound equipment and will not be regulated till 01.11.2021.
Impact Institutional Ethics Committee approval to conduct clinical investigation with Secure Ultrasound system.
Start Year 2019
 
Description Clinical Feasibility of Secure Ultrasound sytem 
Organisation St Johns Research Institute
Country India 
Sector Academic/University 
PI Contribution Preparation of documents (device specification, List of Equipment, instruments and test protocols) and submission for Institutional Ethics Committee (IEC) and regulatory government body to obtain permission to conduct clinical investigation.
Collaborator Contribution Approval from Institutional Ethics Committee of St John's to conduct clinical investigation. Central Drugs Standard Control Organisation (CDSCO) communicated to National Institute of Advanced Studies (NIAS) that the device for feasibility testing is considered equivalent to an ultrasound equipment and will not be regulated till 01.11.2021.
Impact Institutional Ethics Committee approval to conduct clinical investigation with Secure Ultrasound system.
Start Year 2019
 
Description Clinical feedback for system development 
Organisation St Johns Research Institute
Country India 
Sector Academic/University 
PI Contribution Design and Development of lab prototype for Secure Ultrasound including imaging protocol, user interface and measurement system.
Collaborator Contribution Feedback received from Radiologist to make further improvements based on clinical appropriateness and usability, such as imaging protocol, choice of standard planes for measurements, ergonomic considerations for probe housing.
Impact Feedback incorporated into improved design.
Start Year 2018
 
Description Fetal phantom scans at different speeds 
Organisation Cranfield University
Department Centre for Digital Engineering and Manufacturing
Country United Kingdom 
Sector Academic/University 
PI Contribution Assisted collaborators to test a signal processing method by providing controlled data acquired in our lab.
Collaborator Contribution The research was published in IEEE Access.
Impact Research paper was published and DOI link has been provided above.
Start Year 2019
 
Description Probe contact algorithm 
Organisation Cranfield University
Department Centre for Digital Engineering and Manufacturing
Country United Kingdom 
Sector Academic/University 
PI Contribution We proposed that an algorithm to detect inadequate coupling between the ultrasound probe and scanning surface due to lack of gel contact could help in providing feedback on quality of volume reconstructed and that the expertise of the collaborator could be utilised in the algorithm design and implementation. We also suggested improvements in the algorithm that was designed.
Collaborator Contribution The algorithm designed by the collaborator could detect lack of probe contact and has been integrated with Secure Ultrasound system that has been prototyped in the lab and tested with a fetal phantom.
Impact The algorithm is a part of the prototype Secure Ultrasound system.
Start Year 2019
 
Description Ques for AR guidance 
Organisation Cranfield University
Department Centre for Digital Engineering and Manufacturing
Country United Kingdom 
Sector Academic/University 
PI Contribution Suggested the use of point cloud data from an external camera to model scanning surface. Introduced PLUS opensource software to track ultrasound probe through OpenIGTLink.
Collaborator Contribution Exploration of these options - work in progress.
Impact Work in progress
Start Year 2018
 
Description 2018 Engagement Activities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact Engagement activities include: Visit to St. Johns Medical College Hospital (SJMCH), Site visit to semi-urban Government Health Centre located at Sarjapur and also to a semi-urban Private Health Centre located at Sarjapur, Site visit to Rural Public Health Centre (Mugalur). Meeting with IISc and SJNAHS experts to discuss on functional requirements. IISc team visited the Department of Radiology with a custom phantom device to learn the techniques used to capture the 3D and 4D ultrasound images. Site visit and discussion with Stake Holders at Department of Radiology, BSM Medical University Dhaka
Year(s) Of Engagement Activity 2018
 
Description 2019 Engagement Activities 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Study participants or study members
Results and Impact Engagement activities include: Visit to St. Johns Medical College Hospital (SJMCH). Meeting with IISc, NIAS and Cranfield University experts to discuss on functional requirements. IISc, NIAS and Cranfield University team visited the Department of Radiology at St Johns Medical College Hospital to learn the techniques used to capture the 3D and 4D ultrasound images. Site visit included discussions with Stake Holders at the Department of Radiology, and the Department of Obstetrics and Gynecology, St Johns Medical College Hospital.
Year(s) Of Engagement Activity 2019
 
Description 2019 Engagement Activities 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact IISc team visited the Department of Radiology to learn the method used during the Ultrasound scanning process. 3D Ultrasound data was captured and anonymized data was in DICOM Format was analyzed by the IISc team. Measurements were noted and co-related with 23-week Foetal Phantom's measurements.
Year(s) Of Engagement Activity 2019
 
Description Visit to City University London 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact This event involved presenting an overview of the Secure Ultrasound project to practitioners in ultrasound scanning. The event opened up an opportunity exchange knowledge on current practice and helped to identify challenges in the field. There have been further engagements on collaboration opportunities related to GCRF funding and other means.
Year(s) Of Engagement Activity 2019