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CTRI Number  CTRI/2020/08/027008 [Registered on: 05/08/2020] Trial Registered Prospectively
Last Modified On: 10/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Advantage of Artificial Intelligence to detect COVID 19 using Chest X-Ray. 
Scientific Title of Study   Use of artificial intelligence(AI) in detection of COVID 19 case using CXR Data. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Asutosh N Dave 
Designation  Professor and Head, Department of Radio Diagnosis 
Affiliation  GCS Medical College and Hospital 
Address  Department of Radiodiagnosis GCS Medical College and Hospital Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000
Department of Radiodiagnosis. Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000
Ahmadabad
GUJARAT
380015
India 
Phone  9825038648  
Fax    
Email  drasutosh@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asutosh N Dave 
Designation  Professor and Head, Department of Radio Diagnosis 
Affiliation  GCS Medical College and Hospital 
Address  GCS Medical College and Hospital Department of Radiodiagnosis. Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000
Department of Radiodiagnosis. Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000
Ahmadabad
GUJARAT
380015
India 
Phone  9825038648  
Fax    
Email  drasutosh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Asutosh N Dave 
Designation  Professor and Head, Department of Radio Diagnosis 
Affiliation  GCS Medical College and Hospital 
Address  GCS Medical College and Hospital, Department of radiodiagnosis. Opp.D.R.M. Office, Naroda Rd,nr.Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000O.
Department of radiodiagnosis. Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000O.
Ahmadabad
GUJARAT
380015
India 
Phone  9825038648  
Fax    
Email  drasutosh@yahoo.com  
 
Source of Monetary or Material Support  
GCS Medical college and hospital Address: Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000 
 
Primary Sponsor  
Name  Institute of Technology and Institute of Pharmacy NIRMA University 
Address  Sarkhej - Gandhinagar Hwy, Gota, Ahmedabad, Gujarat 382481 Phone: 079 7165 2000 
Type of Sponsor  Other [NIRMA University] 
 
Details of Secondary Sponsor  
Name  Address 
GCS Medical College and Hospital  Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Asutosh N Dave  GCS Medical College and Hospital  Department of Radiodiagnosis. Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Phone: 079 6604 8000
Ahmadabad
GUJARAT 
9825038648

drasutosh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GCS Medical College , Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Chest x-rays taken in department radiodiagnosis, GCSMC. 
 
ExclusionCriteria 
Details  NIL 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare the sensitivity of artificial intelligence in detection of COVID 19 using chest x rays to human radiologist.  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know prevalence of COVID 19 using artificial intelligence in different age and sex groups   2 months 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

AI based Medical Diagnostic System

Detection of COVID 19 through Chest radiography images

 




In Collaboration with Nirma University and GSC Medical college

 




Table of Contents

 

 Chapter 1 Abstract

 Chapter 2 Problem Description

 Chapter 3 Data

 Chapter 4 AI Framework

 

4.1 Classification network

4.2 Generating heatmap

 Chapter 5 Model Details

5.1 Resnet50

 

5.2 Proposed model

5.3 Heatmap generation

 Chapter 6 Additional Experiments

 Chapter 7 Deployment

 Chapter 8 Future Scope


Chapter 1 - Abstract:

Rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), which is responsible for coronavirus disease 2019 (COVID-19), using chest radiography images has life-saving importance for both patients and doctors. Collection of legitimate chest data along with labels is used to train a dense net model with a similar knowledge base whose results are further validated through severity heatmaps. We have had MOU agreement and ties with the Gujarat Cancer Society (GCS) which helps us by providing real world patient data so as to further improve our model classification accuracy.

 Chapter 2 - Problem Description:

Due to the spread of the novel coronavirus, many lives are being lost as the virus is highly contagious. The most accurate test for Covid 19 in present is the RT-PCR test. But one disadvantage of this test is that it takes more than 24 hours for the results after the collection of the sample. This work felicitates a rapid and easy detection of the chances of a person having been infected with novel coronavirus by just analysis of the chest X- ray of the patient. By this at-least doctors can know if the patient should be quarantined until the results of his/her RT-PCR test or not.

 Chapter 3 - Data:

For achieving the task of diagnosing COVID-19 from medical image analysis we collected and combined data from multiple sources and Additional Dataset was provided by the Gujarat Cancer Society



Final Dataset:

 

 

 

Normal

 

COVID-19

 

Training :

 

7966

 

973

 

Testing:

 

100

100

 

Total:

 

8066

 

1073

Total Training Images: 8939 || Total Testing Images: 200

 

  

 Chapter 4 - AI framework:

  

We propose the following pipeline for the detection of COVID-19 from chest radiography images. The pipeline consists of two main modules:

 

 4.1 Classification network:

 We trained Resnet50, deep convolutional architecture with skip connections and identity blocks on the datasewe created by combining several open-source datasets from scratch, for the purpose of classification.

 

Evaluation:-

Test Accuracy: 85%

 

To further improve the credibility of our results we propose transfer learning on the base model Che-x-Net which is trained on the base ChestX-ray14 dataset, which contain112,120 frontal view X-ray images from 30,805 unique patients for detection o14 diseases (mainly pneumonia). Since transfer learning allows us to use the knowledge gained from other tasks in order to tackle new but similar problems effectively, it can also aid our task. In our case, weights of feature extractor/convolutional blocks are kept the same as that of the Che-x-Net fully trained network. We remove the final output layer of the network and add a few dense layers followed by the output layer with 2 neurons (namely: Normal, COVID-19).

The loss function employed is categorical cross-entropy.


 

Evaluation

Test Accuracy: 92%

 

 4.2  Generating Heat map:

  

For the ones classified as COVID19 positive our approach highlights evidence i.e. diseased patches in the radiography images for clinical users to ease their decision to accept or reject a deep learning-based chest radiography diagnosis.

 

 Chapter 5 - Model Details:

 

5.1 ResNet50 (Residual networks):


A convolutional neural network that is 50 layers deep. It employs skip connections that mitigate the problem of vanishing gradients by allowing an alternate shortcut path for the gradient to flow. The ResNet-50 model consists of 5 stages each with a convolution and identity block. Each convolution block has 3 convolution layers and each identity block also has 3 convolution layers.


5.2 Proposed model - COVID19Net:

  

COVID19Net is a 121-layer Dense Convolutional Network (DenseNet) pretrained on the ChestX-ray14 dataset and extended for the dataset created by us for COVID19 diagnosis. DenseNets improve the flow of information and gradients through the network, making the optimization of very deep networks tractable.The final layer is replaced by a few dense layers to be trained on our data. The final 2-neuron dense layer is followed by a softmax function for getting the classification probability.The network is trained end-to-end using Adam with standard parameters ( β1 = 0.9 and β2 = 0.999).We train the model using mini- batches of size 16. We use an initial learning rate of 0.001 that is decayed by a factor of  10 each time the validation loss flattens after an epoch, and pick the model with the lowest validation loss.


 5.3 Heat map generation:

  

We employ a prediction difference method for the visualization of trained models. We find the difference between the pixel values of the image patches in predicted images and image patches in the normal baseline radiography images. This approach generates a relevance score for each pixel which is visualized as a heat map.


Chapter 6 - Additional Experiments:

 

1) Data Pre-processing:

As training data was collected from many different sources it was beneficial to pre- process all the images before feeding them into the network.

Here, we used 2 types of Data Pre-Processing methods:

 A) Gamma - Correction

B) Image Histogram  Equalization


2) Use of Weighted Loss Function:

To overcome the high imbalance in the data-set which contained nearly 8000 normal images and only 1073 covid 19 images we employed a weighted loss function which gave more weight to the class with less number of data points so as to stop the network from being biased to one class.


3) Use of Balanced Data-Set:

To effectively train the model we also tried using random 1073 images from the Normal Class which resulted in the same number of images in both the classes ie Normal and Covid 19. By this, the model got trained on a perfectly balanced dataset.


After all the Experiments the final Test Accuracy obtained is 97%

 Chapter 7 - Deployment:

●    To deploy the model in real-time a web application is prepared with the use of a flask framework. And the model is deployed on an Nvidia V-100 GPU.

●   Additionally, a cropping function is provided for the user to extract the actual areof interest from the chest X-ray.


Chapter 8 - Future Scope:●       

With  increasin size   o accurate  data  the  model  should  be  constantly updated/trained to get an improving classification accuracy.

●    Can also include CT-scans and severity segmentation maps for a holistic medical system development.

●   To collect and store medical details of patients and suggest them possible checkups and remedies on a timely basis.




 


 
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