| CTRI Number |
CTRI/2025/06/088028 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Testing the LIRA AI tool for screening TB from chest X-rays in general hospital settings
|
|
Scientific Title of Study
|
Evaluation of Diagnostic Accuracy and Validation of LIRA: AI-Driven Radiological Software for Tuberculosis Screening and Other Abnormalities in Adult Chest X-Rays |
| Trial Acronym |
EV LIRA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St.Johns Research Institute |
| Address |
Room number 5, Division of Nutrition, 1st floor, St.Johns Research Institute,100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St.Johns Research Institute |
| Address |
Room number 5, Division of Nutrition, 1st floor, St.Johns Research Institute100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St.Johns Research Institute |
| Address |
Room number 5, Division of Nutrition, 1st floor, St.Johns Research Institute,100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| Centre For Advance Research,ICMR |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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 Prashanth T |
St. Johns Research Institute |
Room number 5, Division of Nutrition, 1st floor,100 Feet Rd, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
08049467054
prashanth.t@sjri.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St John’s Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Retrospective Phase: a. Archived chest X-ray images of adult patients, aged 18 years and older , collected within the last 6 months. b. Minimum image resolution of 1440 x 1440 pixels. c. Availability of corresponding microbiological test results. d. No prior diagnosis or treatment for active TB within the past 6 months.
Prospective Phase: a. Adults aged 18 years and above presenting for chest X-rays due to suspected TB. b. Ability to comply with study procedures, including follow-up evaluations. d. No prior diagnosis or treatment for active TB within the past 6 months. |
|
| ExclusionCriteria |
| Details |
Retrospective phase: a. Incomplete or poor-quality CXR images. b. Patients under 18 years of age. c. Absence of corresponding microbiological test results or clinical data. d. Prior diagnosis or treatment for active TB within the past 6 months. Prospective Phase: a. Pregnant or lactating individuals (due to radiation exposure). b. Patients with severe respiratory distress require immediate clinical intervention. c. Patients under 18 years of age. d. Prior diagnosis or treatment for active TB within the past 6 months. e. Inability to comply with the study protocol due to cognitive impairments or severe comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will evaluate the diagnostic accuracy of LIRA in TB screening and detection of other chest abnormalities by comparing its sensitivity and specificity to the performance with that of expert radiologists |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will examine the impact of LIRA on clinical workflow efficiency, diagnostic speed, and the qualitative feedback from radiologists regarding its usability. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="5640"
Sample Size from India="5640"
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)
|
06/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to evaluate the diagnostic accuracy and validate the performance of
LIRA AI Tool, in detecting Pulmonary TB and other key clinical findings or abnormalities from adult chest
X-rays and to compare its results with those of expert radiologists. The objectives of this clinical study are divided into two major group studies: Retrospective study:
The primary objective is to assess LIRA’s sensitivity, specificity, positive predictive value, and
negative predictive value in detecting tuberculosis (TB) versus the reference standard
microbiological confirmation using previously collected chest X-ray data.
The secondary objective is to compare LIRA’s sensitivity, specificity, positive predictive value,
and negative predictive value in detecting tuberculosis (TB) versus a radiologist’s opinion using
previously collected chest X-ray data. Prospective study:
The primary objective is to evaluate LIRA’s accuracy and reliability in real-time TB detection,
aiming to enhance diagnostic speed and efficiency.
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The secondary objective focuses on LIRA’s impact on radiologist workflows, specifically its
integration with PACS, its effect on turnaround times, and its capacity to prioritize high-risk cases
in clinical and community settings. This is a case-control design and prospective cohort study designed to evaluate the clinical efficacy
and diagnostic accuracy of LIRA, an AI-powered radiology software, in identifying abnormalities
associated with tuberculosis (TB) on CXR in AP/PA views. |