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

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT05389774

Run by

Nottingham University Hospitals NHS Trust

People needed

2000

Starts

2023-03-23

Expected to finish

2025-08-01

Last updated by the study team

2025-04-08

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Betsi Cadwaladr University Health Board — Bangor, United Kingdom (enrolling)
• Frimley Health NHS Foundation Trust (Wexham Park Hospital) — Frimley, United Kingdom (enrolling)
• Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
• King's College Hospital NHS Foundation Trust — London, United Kingdom (enrolling)
• Royal Free Hospital — London, United Kingdom (enrolling)
• St. George's University Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
• The Royal Marsden NHS Foundation Trust — London, United Kingdom (enrolling)
• University College London Hospitals NHS Foundation Trust — London, United Kingdom (enrolling)
• Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (enrolling)
• Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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