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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

S

San Donato Group (GSD)

Status

Not yet enrolling

Conditions

Lung Cancer

Treatments

Procedure: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT06963515
IMAGING-SAFE-LUNG

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Antonio A Esposito, MD; Davide Vignale, MD

Data sourced from clinicaltrials.gov

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