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NCT Number: NCT05389774

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

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.

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Key information

Conditions

AI (Artificial Intelligence) Lung Cancer Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Pulmonary Nodule, Multiple Pulmonary Nodule, Solitary Respiratory Tract Diseases Respiratory Tract Neoplasms Solitary Pulmonary Nodule Thoracic Neoplasms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Betsi Cadwaladr University Health Board, Bangor, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the potential effect of the LCP on discharge

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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)

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

    Time frame: up to 1 year.

    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).

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Collaborators

  • Optellum Ltd.

Registry information

Official study title

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

Acronym: DOLCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 25, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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