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

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NHS Trust

Status

Enrolling

Conditions

Pulmonary Nodule, Multiple
Pulmonary Nodule, Solitary
Lung Cancer
AI (Artificial Intelligence)

Study type

Observational

Funder types

Other

Identifiers

NCT05389774
21RM052

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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 measured using manual electronic callipers
  • Have baseline CT study that includes at least one series that meets all of the following (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 degree of contrast media and does not exhibit quality issues (e.g., motion artefacts)

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 fully calcified nodules (this criterion is used as a proxy due to the risk of being an infection or metastasis)

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

    • Are already undergoing follow-up according to pulmonary nodule management standard care
    • Pure ground glass opacity (GGO) of >=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
    • >30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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