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

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