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

Официальное название

GALACTIC 1 - Glasgow Low-dose CT and AI-based Diagnostics to Case Find Lung Cancer and Other Cardio-respiratory Long-term Conditions - Feasibility Study

Обзор

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.

Вмешательства

• Диагностический тест Low dose Chest CT
  Low dose Chest CT

Первичные конечные точки

• 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. [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Sensitivity of LDCT for detecting confirmed lung cancer (proportion of patients with lung cancer correctly identified as positive). [Срок оценки: Baseline]
• Specificity of LDCT for detecting confirmed lung cancer (proportion of patients without lung cancer correctly identified as negative). [Срок оценки: Baseline]
• Lung cancer detection rate [Срок оценки: Baseline]
• Stage distribution of detected lung cancers [Срок оценки: Baseline]
• Detection rate of undiagnosed COPD and/or emphysema in participants. [Срок оценки: Baseline]
• Detection rate of undiagnosed interstitial lung abnormalities (ILA) and pulmonary fibrosis in participants. [Срок оценки: Baseline]
• Detection rate of undiagnosed significant coronary artery disease (CAD) in participants [Срок оценки: Baseline]
• Detection rate of undiagnosed heart failure - radiological, ECG or biomarker (elevated NT-proBNP) indicators requiring further evaluation in participants. [Срок оценки: Baseline]
• Detection rate of undiagnosed osteoporotic fractures in participants. [Срок оценки: Baseline]
• Impact of addressable long-term condition case-finding on subsequent investigations, preventative therapy initiation and clinical outcomes. [Срок оценки: Year 1 and Year 2]
• Performance and potential utility of AI-based radiology co-reporting of lung cancer screening CT scans [Срок оценки: Baseline]
• Acceptability and qualitative evaluation [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 1 центр

• Queen Elizabeth University Hospital — Glasgow

Идентификаторы

NCT: NCT07372508 · INGN25HS173 · IRAS: 357735

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗