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

Lung Cancer Clinical Trial

— DOLCE  

Official title:

DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction (LCP) Artificial Intelligence Solution on Service Utilisation, Health Economics and Patient Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389774
• Other study ID #: 21RM052
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AI (Artificial Intelligence)
• Lung Cancer
• Lung Neoplasms
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Multiple
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
United Kingdom	Betsi Cadwaladr University Health Board	Bangor
United Kingdom	Frimley Health NHS Foundation Trust (Wexham Park Hospital)	Frimley
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St. George's University Hospitals NHS Foundation Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	Optellum Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the potential effect of the LCP on discharge	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)	up to 1 year.
Secondary	Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.	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	up to 1 year.
Secondary	Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.	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	up to 1 year.
Secondary	Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care	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)	up to 1 year.
Secondary	Determine the potential effect of the LCP on possible adherence to clinical guidelines.	Measured difference between standard care and LCP-guided care for : Number and percentage of patients for whom a validated risk model (Brock or LCP) is used to guide the next clinical management step (i.e., counting the instances where Brock is not used, or where LCP is not possible to compute or it is ignored).	up to 1 year.