DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes
Trial ID: NCT05389774
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-03-23
Completion date: 2025-08
Sponsor: Nottingham University Hospitals NHS Trust
Collaborators: Optellum Ltd.
Conditions: AI (Artificial Intelligence); Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple; Lung Cancer
Locations: Betsi Cadwaladr University Health Board; Frimley Health NHS Foundation Trust (Wexham Park Hospital); Leeds Teaching Hospitals NHS Trust; King's College Hospital NHS Foundation Trust; Royal Free Hospital; St. George's University Hospitals NHS Foundation Trust; The Royal Marsden NHS Foundation Trust; University College London Hospitals NHS Foundation Trust; Nottingham University Hospitals NHS Trust; Oxford University Hospitals NHS Foundation Trust
Countries: United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom; United Kingdom
Enrollment: 2000
Age range: 35 Years - None
Sex: ALL

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 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

Outcomes:
Determine the potential effect of the LCP on discharge