| 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
|
|
|
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
|
|
|
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, |
|
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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. |
|
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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 aloneâ€.
(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. |