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

NCT05817110 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 712

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Lung Malignancy

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.

Sponsors & Collaborators

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2026-12-06
Completion
2026-12-06

Countries

  • Egypt
  • India
  • Indonesia
  • Mexico
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817110 on ClinicalTrials.gov