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

A Prospective Real-world Cohort Study to Validate Effectiveness of an Artificial Intelligence defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule - CREATE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/04/051702
Enrollment
700
Registered
2023-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

AstraZenca
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 3. To assess the correlation of qXR-LNMS and the Mayo clinic model 4. Clinically (2yr Follow Up) proven basedTimepoint: 1,2,3 - In one year. 4 - Three years.

Countries

India, Mexico, Turkey

Contacts

Public ContactAkshay Mahale

Qure ai Technologies Private Limited

akshay.mahale@qure.ai9975320085

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026