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NCT Number: 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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Procedure

3T Magnetic Resonance Imaging

Primary outcomes

  1. 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

    Time frame: 3 years

Secondary outcomes

  1. 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.

    Time frame: 3 years

Other outcomes

  1. 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.

    Time frame: 3 years

    The 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.

  2. 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.

    Time frame: 3 years

    The 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio A Esposito, MD

CONTACT

[email protected]

0226436102

Davide Vignale, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 9, 2025
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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