Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study

Patients who have undergone CT that has detected a pulmonary nodule and was performed for a reason other than suspicion of lung cancer will be reviewed for study eligibility (box 1).

Box 1

Patient eligibility criteria

Inclusion criteria

Patients aged 35 years or over.

Patients with a baseline CT study with at least one incidentally detected solid or part-solid pulmonary nodule that is 5–30 mm in maximum axial diameter for the whole lesion, measured using manual electronic callipers, and that is not fully calcified. The solid component of the part-solid nodule must be ≥80% of the total nodule size.

Patients with a baseline CT study which includes at least one series with acquisition parameters which meet Virtual Nodule Clinic requirements.

The patient has a baseline CT study that includes at least one series that comprises at least one full-inspiration breath-hold scan without a high degree of contrast media and does not exhibit quality issues (eg, motion artefacts).

Exclusion criteria

Patients who received a diagnosis of cancer in the last 5 years.

Patients who have thoracic implants that adversely impact the imaging appearances of the nodule.

Patients who have more than five reported pulmonary nodules of any size or type, excluding fully calcified nodules (a marker of prior granulomatous infection) or metastatic lung cancer.

Patients who have one or more additional nodules that are already undergoing follow-up according to pulmonary nodule management standard care.

Patients who have one or more additional nodules that are pure ground glass opacity of 5 mm in maximum axial diameter for the whole lesion measured using manual electronic callipers.

Patients who have one or more additional nodules >30 mm in maximum axial diameter for the whole lesion measured using manual electronic callipers.

Patients with part-solid nodules where the solid component is <80% of the total nodule size.

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