Actively Recruiting

Age: 35Years +
All Genders
ID05389774

DOLCE: Impact of Optellum's Lung Cancer Prediction AI on Health Economics and Patient Outcomes

Led by Nottingham University Hospitals NHS Trust · Updated on 2025-04-08

2000

Participants Needed

10

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nottingham University Hospitals NHS Trust

Lead Sponsor

O

Optellum Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multi-centre prospective observational study to evaluate patients with solid and part-solid pulmonary nodules detected on routine CT chest scans. The goal is to assess whether the use of an AI-based Lung Cancer Prediction (LCP) tool influences physician decision-making and leads to clinical and health-economic benefits compared to the current standard care for these patients. This study focuses on nodules sized between 5 and 30 mm that meet specific imaging criteria. Participants will be observed without any assigned treatments as this is an observational study. The study involves evaluating baseline CT scans that meet defined quality standards and include nodules with a solid component of at least 80%. Training will be provided on the CT scan requirements. No experimental interventions are administered, but the impact of the AI tool on clinical management, use of scans and procedures, adherence to guidelines, and patient outcomes will be studied over up to one year. During the study, researchers will collect data on patient care and outcomes related to pulmonary nodules, including discharge rates and health economics. Assessments will include reviewing clinical decisions, imaging usage, and adherence to guidelines over a one-year period. Participants will be followed through their routine care with no additional treatments required, and their progress will be monitored to measure the potential effects of the AI tool on service utilization and patient outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35 years or older
  • Have a baseline CT scan showing at least one solid or part-solid pulmonary nodule with a solid component of 80% or more
  • Nodule is not fully calcified
  • Nodule size between 5 and 30 mm in maximum axial diameter
  • Baseline CT includes at least one scan series meeting VNC instructions for use
  • Scan includes at least one full-inspiration breath-hold without high contrast media and no major quality issues
Not Eligible

You will not qualify if you...

  • Diagnosis of cancer within the last 5 years
  • Presence of thoracic implants affecting nodule imaging
  • More than five pulmonary nodules reported, excluding fully calcified nodules
  • Additional nodules already under follow-up per standard care
  • Nodules with pure ground glass opacity 5 mm or larger
  • Nodules larger than 30 mm in maximum axial diameter

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are observed to assess the impact of the lung cancer prediction solution on clinical management, procedure use, and patient outcomes over time.

Visits as per routine clinical care up to 1 year

Trial Site Locations

Total: 10 locations

1

Betsi Cadwaladr University Health Board

Bangor, United Kingdom

Actively Recruiting

2

Frimley Health NHS Foundation Trust (Wexham Park Hospital)

Frimley, United Kingdom

Actively Recruiting

3

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Actively Recruiting

4

King's College Hospital NHS Foundation Trust

London, United Kingdom

Actively Recruiting

5

Royal Free Hospital

London, United Kingdom

Actively Recruiting

6

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom

Actively Recruiting

7

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Actively Recruiting

8

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Actively Recruiting

9

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Actively Recruiting

10

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Emma O'Dowd, Marko Berovic, Matthew Callister...

https://pubmed.ncbi.nlm.nih.gov/38176863