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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Not specified by the sponsor
How long the study runs: Study runs about 29 months (dates as stated)
About the drug or intervention: Not specified by the sponsor
Patient visit burden: Not specified by the sponsor

In plain English

This study, run by Nottingham University Hospitals NHS Trust, looks at the impact of Optellum's Lung Cancer Prediction Solution, an artificial intelligence (AI) tool, in people who have lung nodules (small spots in the lung) found on a CT (computed tomography) scan. The tool is designed to help assess the chance that a nodule is lung cancer. What the study involves beyond this is not stated — ask the trial team.

Who can take part

Aged 35 or over
Have a baseline CT scan showing at least one lung nodule found by chance that is solid or mostly solid (at least 80% solid), is not fully calcified (hardened with calcium), and measures 5–30mm across
The CT scan includes at least one good-quality scan taken while holding a deep breath in, with little or no contrast dye, and of a type that meets the rules for use of the study software

Who may not be able to

Have had a cancer diagnosis in the last 5 years
Have implants in the chest that affect how the nodule looks on a scan
Have more than five lung nodules of any size or type (apart from fully calcified ones)
Have any other nodule that is already being monitored as part of normal care, is a pure 'ground glass' type of 5mm or more, or is larger than 30mm

What taking part involves

• Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Observing health over time
Ages: 35 Years and over
Who: All
Number of participants: 2,000
Started: 2023-03-23
Last checked: 2025-04

Plain English Summary

What is this study?

• Testing a new treatment for ai (artificial intelligence)
• Clinical study - 2,000 participants
• 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

Who can take part?

• Ages 35 Years and over
• Diagnosed with ai (artificial intelligence)

Where?

• Bangor - Betsi Cadwaladr University Health Board
• Frimley - Frimley Health NHS Foundation Trust (Wexham Park Hospital)
• Leeds - Leeds Teaching Hospitals NHS Trust
• London - King's College Hospital NHS Foundation Trust
• +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

AI (Artificial Intelligence)Pulmonary Nodule, SolitaryPulmonary Nodule, MultipleLung Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 35 Years and over
Who can join: All genders

Treatment history

Treatments you must have had:

✓ a solid component \>=80%) pulmonary nodule that:

What the study is looking for

✓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...
✓is not fully calcified
✓Is 5-30mm inclusive in maximum axial diameter for the whole lesion measured using manual electronic callipers

Who cannot take part

✗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 lung nodules of any size or type excluding fully calcified nodules (this criterion...
✗Have one or more additional nodules where any of the following applies:

See the full criteria

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