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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06963515
Enrollment
250
Registered
2025-05-09
Start date
2025-06-20
Completion date
2028-06-20
Last updated
2025-05-09

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

Conditions

Lung Cancer

Keywords

Magnetic Resonance Imaging, Low Dose Computed Tomography

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.

Interventions

PROCEDUREMagnetic Resonance Imaging

3T Magnetic Resonance Imaging

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frame
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 LDCT3 years

Secondary

MeasureTime frame
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

Other

MeasureTime frameDescription
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.3 yearsThe following will be used to assess this outcome measures: number of lung cancer cases detected, stage distribution at detection, lung cancer-specific mortality, and overall mortality.
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.3 yearsThe following will be used to assess this outcome measures: total program costs, costs per scan, and scanner operational efficiency (e.g., cost per hour of scanner use).

Contacts

Primary ContactAntonio A Esposito, MD
esposito.antonio@hsr.it0226436102
Backup ContactDavide Vignale, MD
vignale.davide@hsr.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026