AzTrials
AzTrials

Lung CancerNCT06963515

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

An observational study of Lung Cancer, run by IRCCS San Raffaele.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Lung Cancer
What is being tested?
Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
How many people
250 participants
Where
No sites listed yet
Study dates
20 Jun 2025to 20 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Adult, Older adult

Study population: The population will include 250 participants at high risk of lung cancer (smokers over 50 years old) already enrolled in screening programmes undergoing baseline or repeated CT scans.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Antonio A Esposito, MD contact

0226436102

esposito.antonio@hsr.it

Davide Vignale, MD contact

vignale.davide@hsr.it

About this study

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.

Conditions
Lung Cancer
Being tested
Magnetic Resonance Imaging
Keywords
Magnetic Resonance Imaging, Low Dose Computed Tomography
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance ImagingProcedure or surgery

    3T Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Secondary outcomes (1)

  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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start20 Jun 2025 (estimated)
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion20 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963515
Sponsor's protocol ID
IMAGING-SAFE-LUNG
Status last verified
Apr 2025
First submitted
19 Feb 2025
Last updated
9 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21714641

  • 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.

    PubMed 31995683

  • 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.

    PubMed 35354556

  • 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.

    PubMed 37820837

  • 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.

    PubMed 24590022

  • 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.

    PubMed 34846203

  • 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.

    PubMed 24364923

  • 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.

    PubMed 29110848

  • 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.

    PubMed 24004118

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by IRCCS San Raffaele.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonio A Esposito, MD (0226436102, esposito.antonio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963515, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.

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