Cutting-edge IMAGING Technologies to Improve the SAFEty and the Sustainability of LUNG Cancer Screening and the Accuracy of Non-invasive Lung Nodules Characterization
NCT ID: NCT06963515
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2025-06-20
2028-06-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Magnetic Resonance Imaging
3T Magnetic Resonance Imaging
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Antonio Esposito
Professor
Central Contacts
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References
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National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.
Potter AL, Rosenstein AL, Kiang MV, Shah SA, Gaissert HA, Chang DC, Fintelmann FJ, Yang CJ. Association of computed tomography screening with lung cancer stage shift and survival in the United States: quasi-experimental study. BMJ. 2022 Mar 30;376:e069008. doi: 10.1136/bmj-2021-069008.
Christensen J, Prosper AE, Wu CC, Chung J, Lee E, Elicker B, Hunsaker AR, Petranovic M, Sandler KL, Stiles B, Mazzone P, Yankelevitz D, Aberle D, Chiles C, Kazerooni E. ACR Lung-RADS v2022: Assessment Categories and Management Recommendations. J Am Coll Radiol. 2024 Mar;21(3):473-488. doi: 10.1016/j.jacr.2023.09.009. Epub 2023 Oct 10.
McCunney RJ, Li J. Radiation risks in lung cancer screening programs: a comparison with nuclear industry workers and atomic bomb survivors. Chest. 2014 Mar 1;145(3):618-24. doi: 10.1378/chest.13-1420.
Ohno Y, Takenaka D, Yoshikawa T, Yui M, Koyama H, Yamamoto K, Hamabuchi N, Shigemura C, Watanabe A, Ueda T, Ikeda H, Hattori H, Murayama K, Toyama H. Efficacy of Ultrashort Echo Time Pulmonary MRI for Lung Nodule Detection and Lung-RADS Classification. Radiology. 2022 Mar;302(3):697-706. doi: 10.1148/radiol.211254. Epub 2021 Nov 30.
Sommer G, Tremper J, Koenigkam-Santos M, Delorme S, Becker N, Biederer J, Kauczor HU, Heussel CP, Schlemmer HP, Puderbach M. Lung nodule detection in a high-risk population: comparison of magnetic resonance imaging and low-dose computed tomography. Eur J Radiol. 2014 Mar;83(3):600-5. doi: 10.1016/j.ejrad.2013.11.012. Epub 2013 Dec 4.
Heuvelmans MA, Walter JE, Peters RB, Bock GH, Yousaf-Khan U, Aalst CMV, Groen HJM, Nackaerts K, Ooijen PMV, Koning HJ, Oudkerk M, Vliegenthart R. Relationship between nodule count and lung cancer probability in baseline CT lung cancer screening: The NELSON study. Lung Cancer. 2017 Nov;113:45-50. doi: 10.1016/j.lungcan.2017.08.023. Epub 2017 Sep 1.
McWilliams A, Tammemagi MC, Mayo JR, Roberts H, Liu G, Soghrati K, Yasufuku K, Martel S, Laberge F, Gingras M, Atkar-Khattra S, Berg CD, Evans K, Finley R, Yee J, English J, Nasute P, Goffin J, Puksa S, Stewart L, Tsai S, Johnston MR, Manos D, Nicholas G, Goss GD, Seely JM, Amjadi K, Tremblay A, Burrowes P, MacEachern P, Bhatia R, Tsao MS, Lam S. Probability of cancer in pulmonary nodules detected on first screening CT. N Engl J Med. 2013 Sep 5;369(10):910-9. doi: 10.1056/NEJMoa1214726.
Other Identifiers
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IMAGING-SAFE-LUNG
Identifier Type: -
Identifier Source: org_study_id
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