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

NCT05817110

Active Not RecruitingN/A

Sponsor: AstraZeneca

Conditions: Lung Malignancy

Interventions: Participant Cohort

Countries: Egypt, India, Indonesia, Mexico, Turkey (Türkiye)

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.

Eligibility overview

Sex: ALL

Age: 35 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged \>35 years
* Patients diagnosed with incidental pulmonary nodule (IPN) on CXR (chest x-ray) 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
* Nondigital (chest x-ray)CXR
* CT scan is done more than 6 months after (chest x-ray) CXR
* Patients with already diagnosed lung cancer
* The patients referred for an X-Ray for a suspicious Lung cancer
* A patient who already participated in the study.

Locations (22)

Alexandria, Egypt
Cairo, Egypt
Gurugram, Haryana, India
New Delhi, National Capital Territory of Delhi, India
New Delhi, National Capital Territory of Delhi, India
New Delhi, National Capital Territory of Delhi, India
Hyderabad, Telangana, India
Bangalore, India
Bangalore, India
Chennai, India
Chennai, India
Chennai, India
Chennai, India
Chennai, India
Kolkata, India
Mumbai, India
Pune, India
Surabaya, Indonesia
Monterrey, Nuevo León, Mexico
Mexico City, Mexico
Ankara, Turkey, Turkey (Türkiye)
Mersin, Turkey, Turkey (Türkiye)