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CTRI Number  CTRI/2022/04/041873 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 11/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to evaluate the effectiveness of computer artificial inteligence in identifying and classifying abnormalites in chest radiographs 
Scientific Title of Study   "Evaluation of AI performance in detecting lung opacities in chest radiographs and charecterizing them into diffrent subgroups (atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, nodule and pleural effusion)." 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Project no 3753 Version No2.0 Dated 7 July 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suyash Kulkarni  
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiodiagnosis Room no 71, Ground Floor, Main building, Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869488867  
Fax    
Email  suyashkulkarni@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suyash Kulkarni  
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiodiagnosis Room no 71, Ground Floor, Main building, Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9869488867  
Fax    
Email  suyashkulkarni@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suyash Kulkarni  
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Radiodiagnosis Room no 71, Ground Floor, Main building, Parel Mumbai


MAHARASHTRA
400012
India 
Phone  9869488867  
Fax    
Email  suyashkulkarni@yahoo.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel Mumbai,Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suyash Kulkarni  Tata Memorial Hospital  Department of Radiodiagnosis Room No 71, Ground floor, Main building Dr. E. Borges Road, Parel, Mumbai, Maharashtra, 400012
Mumbai
MAHARASHTRA 
9869488867

suyashkulkarni@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified, (2) ICD-10 Condition: J989||Respiratory disorder, unspecified, (3) ICD-10 Condition: A159||Respiratory tuberculosis unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Population aged 15+ presented with respiratory symptoms(cough, breathlessness, hemoptysis, chest pain).
2. Population aged 15+ diagnosed with lung cancer.
3. Populations aged 15+ with active tuberculosis symptoms(fatigue, fever, night sweats, cough, and malaise). 
 
ExclusionCriteria 
Details  1. Pregnant women due to radiation hazards.
2. Age group less than 15 yrs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the accuracy of AI alone for detecting lung opacities in the chest radiograph  6 months post enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the accuracy of radiologist alone to AI and radiologist in detecting abnormal findings in CXR  6 months post enrollment 
To compare the interpretation of radiologist alone to AI and radiologist in detecting abnormal findings in CXR  6 months post enrollment 
 
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)   18/04/2022 
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="1"
Months="0"
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  

Chest radiography, or X-ray, one of the most common imaging exams worldwide, is performed to help diagnose the source of symptoms like cough, fever and pain.

Radiologic evaluation of lung lesions can play many roles including primary detection, narrowing of the differential diagnosis, treatment or surgical planning, and post treatment surveillance.

The chest radiographic findings alone are nonspecific and not sufficient for the definitive diagnosis of pulmonary infection, but it play an important role in patients who are critically ill in intensive care unit, in combination with clinical findings radiographs can substantially improve the accuracy of diagnosis in this disease. Serial radiographs repeated bedside in the critical care setting can also help monitor progression / improvement and thus help with clinical management of the patients(Patino Gonzalez et al., 2020).

Chest radiographs demonstrate normal findings and also help characterizing them into different subgroups (atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, nodule and pleural effusion).) It can also aid in characterizing the disease into benign and malignant.

Radiograph not only helps in detecting lung opacities but also aids in detecting multiple medical and surgical emergencies such as spontaneous pneumothorax,pneumothorax can precipitate a life-threatening emergency due to lung collapse and respiratory or circulatory distress. Pneumothorax is typically detected on chest X-ray (O’Connor & Morgan, 2005).

Large data being processed and due to heavy workload in tertiary centers, there is high chance of missing findings in reporting and there can be delay in reporting.

There is need of system which will assess the radiograph correctly and with less time, which not only raise the momentum in emergency cases but also helps in better utilization of manpower.

 

Application of AI in imaging is evolving and could be valuable tool in improving workflow and workforce efficiency. Many AI algorithms are available in the radiology departments and critical care suites which are designed to identify and flag the findings to the radiologist for second review(Yasaka & Abe, 2018).

The new era of artificial intelligence (AI) has introduced revolutionary data-driven analysis paradigms that have led to significant advancements in information processing techniques in the context of clinical decision-support systems. These advances have created significant impact on rapid diagnosis and has raised the momentum in computational medical imaging applications and also aids in new precision medicine research areas(Trivizakis et al., 2020).

The AIM of current study is 

(a)Imageinterpretation by “AI alone” has similar accuracy to image interpretation by “radiologist alone.”

(b) image interpretation by “ AI+ radiologist” increase the accuracy and reduces the interpretation time compared to image interpretation by “radiologist alone”.

(c) The confidence in diagnostic is increased for radiologists when AI is used in clinical practice.

The study will be conducted in 3 phases:

Phase one:

The performance of AI alone will be evaluated on is set of prior 1000(A+B+C) radiographs composed of:

  • SubsetA 300 chest radiograph randomly selected from a patient population aged 15 plus with respiratory symptoms.
  • Subset B 300 chest radiograph randomly selected from a patient population age of 15 plus diagnosed with lung cancer.
  • Subset C 400 chest radiograph randomly selected from a patient population age and 15 plus with active tuberculosis symptoms.

The performance of TCS will be evaluated as follows:

  • For detection of lung capacity on subject A
  • For detection of nodules on subject B
  • For detection of atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, nodule, and pleural effusion in subjects A, B, and C.

PHASE 2:

The accuracy and the interpretation time of “radiologist” and “AI+ radiologist” for detecting atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, nodule and pleural effusion. The set of1000 chest radiographs will be randomly selected from the CXR exams performed in the outpatient department and in the emergency department at the institution during day 4 months after the installation of AI tools.

PHASE 3:

After phase 2 consultants and residents will fill a survey to indicate their relative confidence in picking findings with and without AI and perceived advantages/disadvantages of reading with AI.

 
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