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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-20

Study Completion Date

2028-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Magnetic Resonance Imaging

3T Magnetic Resonance Imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Antonio Esposito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Antonio A Esposito, MD

Role: CONTACT

0226436102

Davide Vignale, MD

Role: CONTACT

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.

Reference Type BACKGROUND
PMID: 21714641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31995683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35354556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37820837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24590022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34846203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24364923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29110848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24004118 (View on PubMed)

Other Identifiers

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IMAGING-SAFE-LUNG

Identifier Type: -

Identifier Source: org_study_id

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