Glasgow Low-dose CT and AI-based Diagnostics to Case Find Lung Cancer and Other Cardio-respiratory Long-term Conditions - Feasibility Study

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-74
SponsorNHS Greater Glasgow and Clyde

About this trial

Lung cancer is one of the most common and serious cancers in Scotland and is often diagnosed at a late stage. Early detection is crucial to improving survival rates. The value of screening for lung cancer with low-dose CT (LDCT) scans has been established, and these scans can also identify other diagnoses earlier.

Additional tests undertaken alongside the CT scan may add value to the lung cancer screening program being rolled out. This study aims to explore the feasibility and utility of a lung cancer screening program with added heart and breathing tests within a single clinic visit.

A Lung Health Check will be offered to people at higher risk of lung cancer, specifically those aged 55-74 with a history of cigarette smoking. This will include a quick and painless LDCT scan, which uses a small amount of radiation to create detailed images of the lungs to detect lung cancer at an early and more treatable stage.

In this "GALACTIC-1" study, the investigators will explore whether structured reporting of the CT scan, combined with additional tests (blood sample, ECG heart trace, and spirometry breathing test), can help identify conditions such as chronic obstructive pulmonary disease (COPD), lung scarring (pulmonary fibrosis), coronary artery disease, heart failure, and early signs of bone fractures (osteoporosis). This enhanced Lung Health Check may improve overall health by identifying and allowing early management of these conditions.

The investigators plan to use the data from the "GALACTIC-1" study to explore AI performance by comparing it to reporting done by doctors. The results will help shape future rollout of lung cancer screening across Scotland, ensuring it is effective, efficient, and beneficial.

The investigators will also have a focus group with patients and interviews with NHS staff to understand their opinions on the screening.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Resident in South Sector NHS GG&C.

Capacity to undertake informed consent.

No active cancer other than non-melanoma skin cancer, monitored localised prostate cancer or localised treated breast cancer.

Aged 55-74 at date of invitation.

Disqualifiers

CT thorax scan undertaken in prior 12 months.

Does not have capacity to give consent (standard criteria for assessing capacity apply).

Aged <55 or >74 years of age at date of invitation

Weight exceeds restrictions for scanner (>200kg).

Trial design

Design model

Single group

Treatments tested in this trial

  • Low dose Chest CT

    Diagnostic test

    Low dose Chest CT

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: All patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of eligible invited participants who receive all components of the combined low-dose CT (LDCT) screening and AI-assisted cardiorespiratory diagnostic tests within the study active period.

Number of patients successfully screened per protocol within recruitment timelines

Time frame
6 months

Secondary outcomes

1

Sensitivity of LDCT for detecting confirmed lung cancer (proportion of patients with lung cancer correctly identified as positive).

Time frame
Baseline
2

Specificity of LDCT for detecting confirmed lung cancer (proportion of patients without lung cancer correctly identified as negative).

Time frame
Baseline
3

Lung cancer detection rate

Proportion of participants found to have lung cancer

Time frame
Baseline
4

Stage distribution of detected lung cancers

The proportion detected at Stage I/II vs. Stage III/IV

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.