Actively Recruiting

Age: 35Years +
All Genders
NCT05389774

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

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

2000

Participants Needed

10

Research Sites

123 weeks

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

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

Official 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...

  • Aged 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
  • The nodule is not fully calcified
  • Nodule size between 5 and 30 mm inclusive in maximum axial diameter measured manually
  • Baseline CT includes at least one series that meets VNC instructions for use
  • CT scan includes at least one full-inspiration breath-hold scan without high contrast media and no significant quality issues (e.g., motion artefacts)
Not Eligible

You will not qualify if you...

  • Diagnosed with cancer in the last 5 years
  • Have thoracic implants that affect the appearance of the nodule on imaging
  • Have more than five reported pulmonary nodules of any size or type, excluding fully calcified nodules
  • Have additional nodules that are under follow-up according to standard pulmonary nodule care
  • Have pure ground glass opacity nodules 5 mm or larger in maximum axial diameter
  • Have 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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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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DOLCE: Determining the Impact of Optellum's Lung Cancer Prediction Solution | DecenTrialz