DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Determine the potential effect of the LCP on discharge [up to 1 year.]
Measured difference between standard care, LCP and LCP-guided care for: Percentage of cancer patients discharged (straight after assessment of the baseline scan) Percentage of benign-nodule patients discharged (straight after assessment of the baseline scan)
Secondary Outcome Measures
- Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization. [up to 1 year.]
Percentage of cancer patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (correctly by more aggressive management and incorrectly for less aggressive management). Percentage of benign-nodule patients for whom there would have been a change in clinical management by LCP and LCP-guided care compared with the actual (standard) care (incorrectly by more aggressive management and correctly for less aggressive management). Measured difference between standard care, LCP and LCP-guided care for: Percentage of CT scans and PET/CT scans performed on benign-nodule patients Percentage of non-surgical biopsies performed on benign-nodule patients Percentage of surgical excisions on benign-nodule patients
- Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes. [up to 1 year.]
Measured difference between standard care, LCP and LCP-guided care for: Percentage of thoracic, respiratory or vascular events related to biopsies or surgical excisions for lung nodules or suspected lung cancer occurring within 30 days of the procedure on benign-nodule patients Percentage of lung cancers stratified by stage Time in days between nodule detection and lung cancer diagnosis
- Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care [up to 1 year.]
Measured difference between standard care, LCP and LCP-guided care for: The composite standardized GBP costs of all healthcare-related activity for lung nodules or suspected lung cancer Health-related utilities (life years and QALYs)
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients are eligible for the study if all of the following apply:
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Are aged 35 years or above
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Have baseline CT study with at least one incidentally detected solid or part-solid pulmonary nodule that:
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is not fully calcified
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Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers
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Have baseline CT study that includes at least one series that meets all of the following (training for this will be provided):
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Is of a type that meets VNC instructions for use
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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:
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Have received a diagnosis for cancer in the last 5 years
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Have thoracic implants that impact the image appearance of the nodule
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Have more than five reported pulmonary nodules of any size or type excluding fully calcified nodules (marker of infection or metastatic lung cancer)
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Have one or more additional nodules where any of the following applies:
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Are already undergoing follow-up according to pulmonary nodule management standard care
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Pure ground glass opacity (GGO) of >=5mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
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30mm in maximum axial diameter for the whole lesion measured using manual electronic callipers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals of Derby And Burton NHS Foundation Trust | Derby | United Kingdom | ||
| 2 | Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom | ||
| 3 | University Hospitals of Leicester NHS Trust | Leicester | United Kingdom | ||
| 4 | King's College Hospital NHS Foundation Trust | London | United Kingdom | ||
| 5 | Royal Free Hospital | London | United Kingdom | ||
| 6 | St. George's University Hospitals NHS Foundation Trust | London | United Kingdom | ||
| 7 | The Royal Marsden NHS Foundation Trust | London | United Kingdom | ||
| 8 | University College London Hospitals NHS Foundation Trust | London | United Kingdom | ||
| 9 | Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom | ||
| 10 | Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
Sponsors and Collaborators
- Nottingham University Hospitals NHS Trust
- Optellum Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21RM052