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

NCT05389774 | Recruiting

• 1 other identifier: 21RM052
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 10

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.

Conditions

AI (Artificial Intelligence); Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Determine the potential effect of the LCP on overall clinical management, as well as scan and procedure utilization.

  up to 1 year.

• Determine the potential effect of the hypothetical LCP-informed care versus standard care on patient outcomes.

  up to 1 year.

• Determine the potential health-economic effect of the hypothetical LCP-informed care versus standard care

  up to 1 year.

• Determine the potential effect of the LCP on possible adherence to clinical guidelines.

  up to 1 year.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CT scans of patients for whom a pulmonary nodule has been identified will be reviewed for study eligibility by a member of the local site's clinical team for the patient.

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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• Optellum Ltd.: collaborator

Study Sites (10)

Betsi Cadwaladr University Health Board

Bangor, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust (Wexham Park Hospital)

Frimley, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Royal Free Hospital

London, United Kingdom

RECRUITING

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

Related Publications (1)

• O'Dowd E, Berovic M, Callister M, Chalitsios CV, Chopra D, Das I, Draper A, Garner JL, Gleeson F, Janes S, Kennedy M, Lee R, Mauri F, McKeever TM, McNulty W, Murray J, Nair A, Park J, Rawlinson J, Sagoo GS, Scarsbrook A, Shah P, Sudhir R, Talwar A, Thakrar R, Watkins J, Baldwin DR. Determining the impact of an artificial intelligence tool on the management of pulmonary nodules detected incidentally on CT (DOLCE) study protocol: a prospective, non-interventional multicentre UK study. BMJ Open. 2024 Jan 4;14(1):e077747. doi: 10.1136/bmjopen-2023-077747.

  PMID: 38176863 DERIVED

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 25, 2022
• Study Start: March 23, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

GB (10)