Cutting-edge IMAGING Technologies to Improve the SAFEty and the Sustainability of LUNG Cancer Screening and the Accuracy of Non-invasive Lung Nodules Characterization

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06963515
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

Low-dose computed tomography (LDCT) is used in individuals at high risk of developing lung cancer (smokers over 50 years of age), as it allows for the identification of pulmonary nodules, which, in a small percentage of cases, may represent early-stage lung cancer. However, according to LUNG-RADS guidelines, individuals undergoing screening must repeat multiple LDCT scans, as the comparison between successive LDCT scans enables the assessment of existing nodules' progression and the identification of newly developed pulmonary nodules. This results in cumulative exposure to ionizing radiation, increasing the risk of radiation-induced cancers.

This study addresses, through the implementation of new imaging techniques utilizing the latest and most advanced technological innovation (high-field 3T Magnetic Resonance Imaging (MRI) with artificial intelligence), the critical challenge of reducing radiation exposure in current LDCT-based screening programs, proposing the use of MRI as an alternative screening method to LDCT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-19
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Study Start: 2025-06-20
• Primary Completion: 2027-06-20
• Study Completion: 2028-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Age ≥ 18 years
• Indication to first lung cancer screening with LDCT according to international guidelines
• Indication to repeated lung cancer screening with LDCT according to international guidelines

Exclusion Criteria

• Age < 18 years
• contraindication to MRI
• presence of metallic implants likely to hamper MRI image quality
• inability to hold breath for 15-20 seconds
• claustrophobia
• refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the sensitivity and specificity for lung nodule detection of a Single Breath- Hold Lung non-contrast MRI scan (SBH-Lung-MRI), lasting less than 20 seconds, in comparison to LDCT	3 years

Secondary Outcome Measures

Name	Time	Method
the sensitivity and specificity for lung nodule detection of SBH-Lung-MRI, lasting less than 20 seconds, in comparison to two of the most accurate available sequences for MRI lung nodule detection, namely: 2D-UTE and spiral 3D- UTE MRI sequences.	3 years