What is this study trying to find out about lung nodules?

This study aims to find out if using an AI-based Lung Cancer Prediction tool helps doctors make better decisions for patients with pulmonary nodules seen on CT scans. Researchers want to see if this tool improves clinical care and health economics compared to usual practices. The study is sponsored by Nottingham University Hospitals NHS Trust and observes real-world patient management.

Who may be eligible for this lung nodule clinical trial?

Adults aged 35 or older with a solid or part-solid lung nodule between 5 and 30 mm seen on a chest CT scan may be eligible. Anyone with a cancer diagnosis in the last 5 years or more than five lung nodules is excluded. There is no gender restriction. Please review eligibility criteria for more details.

Is there any cost to participate in this lung nodule clinical trial?

Study-related care, including all trial visits and evaluations, is provided at no cost. However, personal travel expenses to attend appointments may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel needs.

Actively Recruiting

Age: 35Years +

All Genders

ID05389774

DOLCE Impact of Optellums Lung Cancer Prediction AI on Health Economics and Patient Outcomes

Led by Nottingham University Hospitals NHS Trust · Updated on 2025-04-08

2000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a multi-centre prospective observational study to evaluate patients with solid and part-solid pulmonary nodules detected on routine CT chest scans. The goal is to assess whether the use of an AI-based Lung Cancer Prediction LCP tool influences physician decision-making and leads to clinical and health-economic benefits compared to the current standard care for these patients. This study focuses on nodules sized between 5 and 30 mm that meet specific imaging criteria. Participants will be observed without any assigned treatments as this is an observational study. The study involves evaluating baseline CT scans that meet defined quality standards and include nodules with a solid component of at least 80. Training will be provided on the CT scan requirements. No experimental interventions are administered, but the impact of the AI tool on clinical management, use of scans and procedures, adherence to guidelines, and patient outcomes will be studied over up to one year. During the study, researchers will collect data on patient care and outcomes related to pulmonary nodules, including discharge rates and health economics. Assessments will include reviewing clinical decisions, imaging usage, and adherence to guidelines over a one-year period. Participants will be followed through their routine care with no additional treatments required, and their progress will be monitored to measure the potential effects of the AI tool on service utilization and patient outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 35 years or older
Have a baseline CT scan showing at least one solid or part-solid pulmonary nodule with a solid component of 80% or more
Nodule is not fully calcified
Nodule size between 5 and 30 mm in maximum axial diameter
Baseline CT includes at least one scan series meeting VNC instructions for use
Scan includes at least one full-inspiration breath-hold without high contrast media and no major quality issues

You will not qualify if you...

Diagnosis of cancer within the last 5 years
Presence of thoracic implants affecting nodule imaging
More than five pulmonary nodules reported, excluding fully calcified nodules
Additional nodules already under follow-up per standard care
Nodules with pure ground glass opacity 5 mm or larger
Nodules larger than 30 mm in maximum axial diameter

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