| CTRI Number |
CTRI/2025/04/083926 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Artificial Intelligence to Analyze CT Scans For Lung Emphysema |
|
Scientific Title of Study
|
Application/API Based Artificial Intelligence Enhanced Analysis Of Pulmonary Emphysema Using Computed Tomography Imaging Of Thorax |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Michael Antony Vikram |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences |
| Address |
Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
8610774083 |
| Fax |
|
| Email |
mikevikram97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Muthiah Pitchandi |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences |
| Address |
Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India
Chennai TAMIL NADU 602105 India |
| Phone |
9843175404 |
| Fax |
|
| Email |
drmuthiahmd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Michael Antony Vikram |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences |
| Address |
Room no.50, Department of Radiology, Saveetha Medical College And Hospital, Saveetha Institute Of Medical And Technical Sciences,Saveetha Nagar,Thandalam, Chennai, India
TAMIL NADU 602105 India |
| Phone |
8610774083 |
| Fax |
|
| Email |
mikevikram97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Dr. Michael Antony Vikram |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam,
Chennai-602105
|
| Type of Sponsor |
Other [[SELF]] |
|
|
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 Michael Antony Vikram |
Saveetha Medical College And Hospital |
Room no 50, Department of
Radiology, Saveetha Medical College
Hospital, Saveetha Nagar, Thandalam, Chennai.
Chennai TAMIL NADU |
8610774083
mikevikram97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J439||Emphysema, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Population Criteria: Individuals at varying stages of emphysema risk, including patients with existing CT scans and relevant data.
2.Medical History: Patients with complaints of new onset of breathlessness/documented respiratory conditions (including emphysema and related lung diseases)
3.CT Scan Data: High-quality CT scans showing clear lung structures.
4.Patients of both gender.
5.Patients who have provided informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients who are pregnant.
2.Individuals with other chronic diseases, such as cancer, auto-immune disorders which might affect the study results, will not be included.
3.Patients with surgical history (especially involving the thorax)
4.Individuals with CT Scans of poor quality or artifacts that may compromise accurate assessment of lung parenchyma.
5.Patients who are unable to provide informed consent or participate in the study due to cognitive impairment, language barriers, or other reasons.
6.Patients who are not willing to be part of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To detect the presence of emphysema using AI-driven analysis of CT scans of thorax |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the accuracy and clinical utility of the AI model. |
1 week. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
15/04/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 invention provides a novel, AI-powered solution for the automated detection and quantification of emphysema using CT thorax imaging. Emphysema, a major component of Chronic Obstructive Pulmonary Disease (COPD), is traditionally assessed through manual interpretation of CT scans, which is time-consuming, subjective, and prone to interobserver variability. This invention addresses these limitations by introducing an application/API module that integrates advanced AI algorithms with existing medical imaging systems. The core of the invention is an AI-based mobile application and API interface designed to process CT thorax images, enabling precise analysis of lung parenchyma. The AI algorithms are trained on extensive datasets to detect subtle patterns of emphysema, classify subtypes, and provide quantitative metrics of disease severity and progression. Results are delivered in real time, ensuring prompt feedback for clinical decision-making. The system is equipped with a user-friendly mobile interface that facilitates seamless uploading of CT images, real-time processing via cloud-based infrastructure, and intuitive presentation of results. It is scalable, adaptable to diverse healthcare settings, and supports integration with existing imaging workflows, enabling widespread adoption. Additionally, the invention provides opportunities for use in telemedicine, remote consultations, and longitudinal disease monitoring. This invention offers a transformative approach to emphysema assessment, improving diagnostic accuracy, reproducibility, and efficiency. It aligns with the evolving needs of precision medicine in respiratory care and contributes to advancements in clinical practice, research, and patient outcomes. |