DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution

Last updated: April 4, 2025
Sponsor: Nottingham University Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Pulmonary Nodules

Cancer

Treatment

N/A

Clinical Study ID

NCT05389774
21RM052
  • Ages > 35
  • All Genders

Study Summary

This study is a multi-centre prospective observational cohort study recruiting patients with 5-30mm solid and part-solid pulmonary nodules that have been detected on CT chest scans performed as part of routine practice. The aim is to determine whether physician decision making with the AI-based LCP tool, generates clinical and health-economic benefits over the current standard of care of these patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients are eligible for the study if all of the following apply:

  • Are aged 35 years or above

  • Have baseline CT study with at least one incidentally detected solid or part-solid (must have a solid component >=80%) pulmonary nodule that:

  • is not fully calcified

  • Is 5-30mm inclusive in maximum axial diameter for the whole lesion measuredusing manual electronic callipers

  • Have baseline CT study that includes at least one series that meets all of thefollowing (training for this will be provided):

  • Is of a type that meets VNC instructions for use

  • Comprises at least one full-inspiration breath-hold scans without a high degreeof contrast media and does not exhibit quality issues (e.g., motion artefacts)

Exclusion

Exclusion Criteria:

Patients will be excluded from the study if any of the following apply:

  • Have received a diagnosis for cancer in the last 5 years

  • Have thoracic implants that impact the image appearance of the nodule

  • Have more than five reported pulmonary nodules of any size or type excluding fullycalcified nodules (this criterion is used as a proxy due to the risk of being aninfection or metastasis)

  • Have one or more additional nodules where any of the following applies:

  • Are already undergoing follow-up according to pulmonary nodule managementstandard care

  • Pure ground glass opacity (GGO) of >=5mm in maximum axial diameter for thewhole lesion measured using manual electronic callipers

  • >30mm in maximum axial diameter for the whole lesion measured using manualelectronic callipers

Study Design

Total Participants: 2000
Study Start date:
March 23, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Betsi Cadwaladr University Health Board

    Bangor,
    United Kingdom

    Active - Recruiting

  • University Hospitals of Derby And Burton NHS Foundation Trust

    Derby,
    United Kingdom

    Site Not Available

  • Frimley Health NHS Foundation Trust (Wexham Park Hospital)

    Frimley,
    United Kingdom

    Active - Recruiting

  • Leeds Teaching Hospitals NHS Trust

    Leeds,
    United Kingdom

    Active - Recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester,
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St. George's University Hospitals NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • The Royal Marsden NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • University College London Hospitals NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham,
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford,
    United Kingdom

    Active - Recruiting

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