| CTRI Number |
CTRI/2023/04/051702 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study to measure the impact of using AI in patients with lung nodule. |
|
Scientific Title of Study
|
A Prospective Real-world Cohort Study to Validate Effectiveness of an Artificial Intelligence defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule |
| Trial Acronym |
CREATE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Mahale |
| Designation |
Study Delivery Associate |
| Affiliation |
Qure ai Technologies Private Limited |
| Address |
Qure ai Technologies Private Limited
Address- level 7, Commerz II, International Business Park, Oberoi Garden City, OFF. W.E. Highway, Goregaon (E) Mumbai-400063
Mumbai (Suburban)
MAHARASHTRA
400063
India |
| Phone |
9975320085 |
| Fax |
|
| Email |
akshay.mahale@qure.ai |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshay Mahale |
| Designation |
Study Delivery Associate |
| Affiliation |
Qure ai Technologies Private Limited |
| Address |
Qure ai Technologies Private Limited
Address- level 7, Commerz II, International Business Park, Oberoi Garden City, OFF. W.E. Highway, Goregaon (E) Mumbai-400063
MAHARASHTRA
400063
India |
| Phone |
9975320085 |
| Fax |
|
| Email |
akshay.mahale@qure.ai |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Mahale |
| Designation |
Study Delivery Associate |
| Affiliation |
Qure ai Technologies Private Limited |
| Address |
Qure ai Technologies Private Limited
Address- level 7, Commerz II, International Business Park, Oberoi Garden City, OFF. W.E. Highway, Goregaon (E) Mumbai-400063
MAHARASHTRA
400063
India |
| Phone |
9975320085 |
| Fax |
|
| Email |
akshay.mahale@qure.ai |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AstraZenca |
| Address |
1 Francis Crick Avenue, Cambridge Biomedical
Campus, Cambridge CB2 0AA, England |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Mexico
Turkey |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priyanka Vijay Kesarkar |
AARTHI SCANS & LABS |
X-ray room no_06, SHOP NO 1, 2 AND OFFICE NO. 7, ON GROUND FLOOR, Audumber Haritage, 430/1, Mangalwar Peth Rd, Mangalwar Peth, Kasba Peth, Pune, Maharashtra 411011.
Pune
MAHARASHTRA |
7506312393
kesarkar.priyanka1121@yahoo.com |
| Dr Leena Balusamy Krishnakumar |
Aarthi Scans & Labs Ambattur |
520/3, MTH Road, Ambattur OT, near SHAH Electronics, West Krishnapuram, Chennai, Tamil Nadu 600053
Chennai
TAMIL NADU |
9790825232
leenakandeeban@gmail.com |
| Dr Anil R |
Aarthi Scans & Labs Andheri |
ECO Heights,Shop No.2 Nityanand nagar, Sahar road Next to Sanjeevani Hospital Near Western railway colony Near Flyover bridge, Andheri East, Andheri, Maharashtra 400069
Mumbai
MAHARASHTRA |
9739004123
dranilsmg@gmail.com |
| Dr Hema Devi |
Aarthi Scans & Labs Anna Nagar |
2107, 13th Main Rd, L Block, Anna Nagar West, Anna Nagar, Chennai, Tamil Nadu 600040
Chennai
TAMIL NADU |
9842673834
drhemadevy@gmail.com |
| Dr Kusum Pathania |
Aarthi Scans & Labs Bhawanipore |
6, Sambhunath Pandit St, behind SSKM Hospital, opposite Gurudwara, Bhowanipore, Kolkata, West Bengal 700025, India
Kolkata
WEST BENGAL |
9717656118
kusumpathania20@gmail.com |
| Dr Monica Sampath Kumar |
Aarthi Scans & Labs Indiranagar |
499, Chinmaya Mission Hospital Rd, Indira Nagar 1st Stage, Stage 1, Indiranagar, Bengaluru, Karnataka 560038
Bangalore
KARNATAKA |
7397476087
monz.moonica@gmail.com |
| Dr Varsha Tyagi |
Aarthi Scans & Labs Jaya Nagar |
156, 9th Main Rd, Jaya Nagar 1st Block, Jayanagar 3rd Block, Jayanagar, Bengaluru, Karnataka 560011, India
Bangalore
KARNATAKA |
7838490954
tyagivarsha410.vt@gmail.com |
| Dr Anandhi Ramamurthy |
Aarthi Scans & Labs Porur |
4, 10, Arcot Rd, Lakshmi Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
9841974220
dranandhikgmch@gmail.com |
| Dr Jayanth Murugan |
Aarthi Scans & Labs Tambaram |
116, Elumalai St, Tambaram West, Tambaram, Chennai, Tamil Nadu 600045
Chennai
TAMIL NADU |
9884433262
mappy49@gmail.com |
| Dr Stevie Edwards Mohan Edwards |
Aarthi Scans & Labs Vadapalani |
60, 100 Feet Rd, Vadapalani, Chennai, Tamil Nadu 600026
Chennai
TAMIL NADU |
9940110502
stevieedwards2007@gmail.com |
| Dr Prem Kumar Ganesan |
DR B L KAPUR MEMORIAL HOSPITAL |
Pusa Rd, Rajendra Place, New Delhi, Delhi, 110005
New Delhi
DELHI |
7409382830
drgpremkumar@blkhospital.com |
| Dr Vandana Khandelwal |
Max Smart Super Speciality Hospital |
Mandir Marg, Press Enclave Road, Saket, New Delhi – 110017
New Delhi
DELHI |
7409382830
vandana.khandelwal@maxhealthcare.com |
| Dr Bharat Aggarwal |
Max Super Speciality Hospital, Saket (West block), (A Unit of Max Healthcare Institute Limited ) |
1, Press Enclave Road, Saket, New Delhi – 110017
New Delhi
DELHI |
7409382830
bharat.aggarwal@maxhealthcare.com |
| Dr Anuradha Sural |
Max Super Speciality Hospital, Vaishali (A Unit of Crosslay Remedies Limited ) |
W-3, Sector-1 Vaishali, Ghaziabad, 201012
New Delhi
DELHI |
9899104002
anuradha.sural@gmail.com |
| Dr Randeep Guleria |
Medanta–The Medicity |
Medanta- The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001, India
Gurgaon
HARYANA |
8287838953
randeep.guleria@medanta.org |
| Akhil Kumar |
Yashoda Hospital, Secunderabad |
Alexander Rd, Kummari Guda, Shivaji Nagar, Secunderabad, Telangana 500003
Hyderabad
TELANGANA |
9966166070
akhil.kumar0595@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
| DR B L KAPUR MEMORIAL HOSPITAL ETHICS COMMITTEE ACADEMIC AFFAIRS RESEARCH AND CONTINUING EDUCATION |
Approved |
| Indira Ivf hospital ethics committee |
Approved |
| Indira Ivf hospital ethics committee |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital Vaishali |
Approved |
| Institutional Ethics Committee Yashoda Academy of Medical Education and Research |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| Max Healthcare Ethics Committee - Protocol Version 1.1 dated 24 Feb 2025 |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
| RIPON INDEPENDENT ETHICS COMMITTEE |
Approved |
| ROYAL PUNE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Lung Nodule Incidental Screening |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with incidental pulmonary nodules on CXR by qXR and confirmed by the radiologist at the site with nodule size ≥8 and ≤30 mm. |
|
| ExclusionCriteria |
| Details |
1. Any medical or other contraindications for a CT scan
2. Nondigital CXR
3. CT scan is done more than 6 months after CXR
4. Patients with already diagnosed LC
5. The patients referred for an X-Ray for a suspicious LC
6. A patient who already participated in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. PPV of qXR-LNMS using a panel of radiologists assigning high-risk based on CT (done
within 180 days from Xray) as the reference standard
2. NPV of qXR-LNMS using panel of radiologists assigning low-risk based on CT (done
within 180days from Xray) as reference standard |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. PPV of qXR-LNMS using panel of radiologists assigning Lung-RADS4A based on CT as reference standard
2. PPV of qXR-LNMS using panel of radiologists assigning Lung-RADS4A based on CT as reference standard
3. To assess the correlation of qXR-LNMS and the Mayo clinic model
4. Clinically (2yr Follow Up) proven based |
1,2,3 - In one year.
4 - Three years. |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="300"
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)
|
20/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational multi-center study to analyze the effectiveness of using Artificial Intelligence (AI) on Chest X-rays to identify lung nodules. The study will be conducted in 3 countries India, Turkey, and a country in South America. The primary outcome measure will be the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the AI algorithm in identifying high and low-risk nodules. The secondary outcomes will be PPV and NPV subclassified based on Lung-RADS score (4A), comparison of AI result with Mayo Clinic Score & 2-year follow-up data provided by the patient. |