Clinical trial NCT06963515: Cutting-edge IMAGING Technologies to Improve the SAFEty and the Sustainability of LUNG Cancer Screening and the Accuracy of Non-invasive Lung Nodules Characterization
Official title: Cutting-edge IMAGING Technologies to Improve the SAFEty and the Sustainability of LUNG Cancer Screening and the Accuracy of Non-invasive Lung Nodules Characterization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: Magnetic Resonance Imaging
Low Dose Computed Tomography
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include 250 participants at high risk of lung cancer (smokers over 50 years old) already enrolled in screening programmes undergoing baseline or repeated CT scans.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 years
Secondary outcomes:
measure: 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.
timeFrame: 3 years
Other outcomes:
measure: The health impact of implementing a radiation-free MRI-based lung cancer screening program using the SBH-Lung-MRI approach compared to conventional LDCT screening.
timeFrame: 3 years
measure: The cost-effectiveness of implementing a radiation-free MRI-based lung cancer screening program using the SBH-Lung-MRI approach tested in specific aim 1 compared to conventional LDCT screening.
timeFrame: 3 years
Locations:
Study officials:
References:
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