- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07372508
Glasgow Low-dose CT and AI-based Diagnostics to Case Find Lung Cancer and Other Cardio-respiratory Long-term Conditions - Feasibility Study (GALACTIC-1)
GALACTIC 1 - Glasgow Low-dose CT and AI-based Diagnostics to Case Find Lung Cancer and Other Cardio-respiratory Long-term Conditions - Feasibility Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clare Dolan
- Phone Number: 0141 314 4328
- Email: clare.dolan3@nhs.scot
Study Locations
-
-
-
Glasgow, United Kingdom
- Queen Elizabeth University Hospital
-
Contact:
- Clare Dolan
- Phone Number: 0141 314 4328
- Email: clare.dolan3@nhs.scot
-
Principal Investigator:
- Geesh Jayasekera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Smoking history: current tobacco smoker or ex-smoker with >20 pack year history and <15 years from quit date.
Exclusion Criteria:
- 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).
- Unable to lie flat.
- People who are pregnant.
- Active symptoms of possible lung cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: All patients
|
Low dose Chest CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 6 months
|
Number of patients successfully screened per protocol within recruitment timelines
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of LDCT for detecting confirmed lung cancer (proportion of patients with lung cancer correctly identified as positive).
Time Frame: Baseline
|
Baseline
|
|
|
Specificity of LDCT for detecting confirmed lung cancer (proportion of patients without lung cancer correctly identified as negative).
Time Frame: Baseline
|
Baseline
|
|
|
Lung cancer detection rate
Time Frame: Baseline
|
Proportion of participants found to have lung cancer
|
Baseline
|
|
Stage distribution of detected lung cancers
Time Frame: Baseline
|
The proportion detected at Stage I/II vs. Stage III/IV
|
Baseline
|
|
Detection rate of undiagnosed COPD and/or emphysema in participants.
Time Frame: Baseline
|
Baseline
|
|
|
Detection rate of undiagnosed interstitial lung abnormalities (ILA) and pulmonary fibrosis in participants.
Time Frame: Baseline
|
Baseline
|
|
|
Detection rate of undiagnosed significant coronary artery disease (CAD) in participants
Time Frame: Baseline
|
Baseline
|
|
|
Detection rate of undiagnosed heart failure - radiological, ECG or biomarker (elevated NT-proBNP) indicators requiring further evaluation in participants.
Time Frame: Baseline
|
Baseline
|
|
|
Detection rate of undiagnosed osteoporotic fractures in participants.
Time Frame: Baseline
|
Baseline
|
|
|
Impact of addressable long-term condition case-finding on subsequent investigations, preventative therapy initiation and clinical outcomes.
Time Frame: Year 1 and Year 2
|
Accessible health records, investigation requests, prescriptions, hospital admissions and survival at year 1 and year 2 post Galactic-1 clinic will be reviewed to determine the impact the LDCT had on the patient's care.
|
Year 1 and Year 2
|
|
Performance and potential utility of AI-based radiology co-reporting of lung cancer screening CT scans
Time Frame: Baseline
|
Number of radiology reports which agree with the AI report
|
Baseline
|
|
Acceptability and qualitative evaluation
Time Frame: Baseline
|
Participant experience questionnaires will be collected during GALACTIC-1 clinic to provide an overview of experienced acceptability at the time of clinic attendance.
Additional focus group or semi-structured interviews will be conducted.
|
Baseline
|
|
The potential cost-effectiveness of AI-detection of early-stage lung cancer as well as other conditions such as COPD, pulmonary fibrosis, coronary artery disease, heart failure, and osteoporotic fractures
Time Frame: Year 2
|
Year 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chris Carlin, NHSGGC
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INGN25HS173
- IRAS: 357735 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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