Status:
RECRUITING
DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
Optellum Ltd.
Conditions:
AI (Artificial Intelligence)
Pulmonary Nodule, Solitary
Eligibility:
All Genders
35+ years
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05389774
Start Date
March 23 2023
End Date
August 1 2025
Last Update
April 8 2025
Active Locations (10)
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1
Betsi Cadwaladr University Health Board
Bangor, United Kingdom
2
Frimley Health NHS Foundation Trust (Wexham Park Hospital)
Frimley, United Kingdom
3
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
4
King's College Hospital NHS Foundation Trust
London, United Kingdom