NCT05817110Active, not recruiting
Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.
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.
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 712 (actual)
- First submitted
- 14 Mar 2023
- Start date
- 20 Apr 2023
- Primary completion date
- 6 Dec 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer
- NCT number
- NCT05817110
What you commit to
- Study type: Observational
- Participants enrolled: 712
- From 20 Apr 2023 to the primary completion date, 6 Dec 2026
- 15 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with already diagnosed lung cancer
- The patients referred for an X-Ray for a suspicious Lung cancer
Other
- 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
- A patient who already participated in the study.
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
- Evaluation of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Incidental Pulmonary Nodules: The CREATE Study.Mayo Clin Proc Digit Health · 2026 · PMID 41716936
This page is information, not medical advice. Discuss any trial with your doctor.