Clinical study to measure the impact of using AI in patients with lung nodule.

Active, not recruiting

• Conditions: Lung Nodule Incidental Screening

• Registration Number: CTRI/2023/04/051702
• Lead Sponsor: AstraZenca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-20
• Last Update Posted: 2025-06-20

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. PPV of qXR-LNMS using a panel of radiologists assigning high-risk based on CT (done	One year
within 180 days from Xray) as the reference standard	One year
2. NPV of qXR-LNMS using panel of radiologists assigning low-risk based on CT (done	One year
within 180days from Xray) as reference standard	One year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

AARTHI SCANS & LABS; 🇮🇳 Pune, MAHARASHTRA, India

Aarthi Scans & Labs Ambattur; 🇮🇳 Chennai, TAMIL NADU, India

Aarthi Scans & Labs Andheri; 🇮🇳 Mumbai, MAHARASHTRA, India

Aarthi Scans & Labs Anna Nagar; 🇮🇳 Chennai, TAMIL NADU, India

Aarthi Scans & Labs Bhawanipore; 🇮🇳 Kolkata, WEST BENGAL, India

Aarthi Scans & Labs Indiranagar; 🇮🇳 Bangalore, KARNATAKA, India

Aarthi Scans & Labs Jaya Nagar; 🇮🇳 Bangalore, KARNATAKA, India

Aarthi Scans & Labs Porur; 🇮🇳 Chennai, TAMIL NADU, India

Aarthi Scans & Labs Tambaram; 🇮🇳 Chennai, TAMIL NADU, India

Aarthi Scans & Labs Vadapalani; 🇮🇳 Chennai, TAMIL NADU, India

Scroll for more (6 remaining)

AARTHI SCANS & LABS

🇮🇳Pune, MAHARASHTRA, India

Dr Priyanka Vijay Kesarkar

Principal investigator

7506312393

kesarkar.priyanka1121@yahoo.com