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ACTIVE NOT RECRUITING
NCT05817110

Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Qure.ai, an AI company specializing in the reading of chest X- Rays (CXRs) by a proprietary algorithm and has developed a new model, qXR, that can report the lung nodule malignancy score (LNMS) based on lung nodule features. Our study aims to prospectively validate the lung nodule malignancy score against radiologist assessment of CT scans and Lung CT Screening Reporting and Data System score (Lung-RADS).(lung RADS score explained below) Thus, lung nodule malignancy score (interpreted by qXR as a high or low category) will be compared with radiologist-based assessment probability of CT scan and Lung-RADS assessment. The results of this prospective observational study will pave the way for improved nodule management, leading to better clinical outcomes in patients with incidental pulmonary nodule (IPNs), especially concerning malignancy assessment.

Official title: Prospective Realworld Cohort Study to Validate Effectiveness of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule Multicentric, Multinational, Prospective, Observational Study.

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

OBSERVATIONAL

Enrollment

712

Start Date

2023-04-20

Completion Date

2026-12-06

Last Updated

2026-02-12

Healthy Volunteers

No

Conditions

Interventions

OTHER

Participant Cohort

Patients coming to the facility for chest x-rays for any reason, will undergo x-rays as ordered by their treating clinician. In case of any nodule detection by qXR, it will be classified either as low-risk (Lung nodule malignancy score ) LNMS or high-risk LNMS confirmed by radiologist. Then if patient is eligible will be included in the study and a CT Scan will be requested upon enrolment of the patient.

Locations (22)

Research Site

Alexandria, Egypt

Research Site

Cairo, Egypt

Research Site

Gurugram, Haryana, India

Research Site

New Delhi, National Capital Territory of Delhi, India

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New Delhi, National Capital Territory of Delhi, India

Research Site

New Delhi, National Capital Territory of Delhi, India

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Hyderabad, Telangana, India

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Bangalore, India

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Bangalore, India

Research Site

Chennai, India

Research Site

Chennai, India

Research Site

Chennai, India

Research Site

Chennai, India

Research Site

Chennai, India

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Kolkata, India

Research Site

Mumbai, India

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Pune, India

Research Site

Surabaya, Indonesia

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Monterrey, Nuevo León, Mexico

Research Site

Mexico City, Mexico

Research Site

Ankara, Turkey (Türkiye)

Research Site

Mersin, Turkey (Türkiye)