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Набор скоро начнётся NCT07280559

Evaluation of AI-assisted LDCT Screening in Lung Cancer

Без фазы С лечением Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AI-assisted Low-Dose CT Interpretation.
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 40 лет — 74 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of AI Medical Software-assisted LDCT Interpretation in Lung Cancer Screening and Prognosis: a Randomized Controlled Trial

Обзор

This multicenter pragmatic randomized controlled trial evaluates whether AI-assisted interpretation of low-dose CT (LDCT) improves lung cancer screening performance compared with standard reading. Eligible participants are randomized to AI-assisted or conventional interpretation. The study assesses diagnostic accuracy, efficiency, lung cancer incidence, mortality, recurrence, and smoking cessation outcomes. Results will inform the clinical utility and potential implementation of AI-assisted LDCT in routine screening practice.

Подробное описание

Lung cancer is a leading cause of cancer-related mortality worldwide, and early detection is essential for improving survival. Low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality in high-risk populations, but image interpretation is time-consuming and may lead to overdiagnosis. Artificial intelligence (AI)-assisted diagnostic tools offer the potential to improve accuracy and efficiency in LDCT-based lung cancer screening, though challenges related to model adaptability, data heterogeneity, user trust, and regulatory compliance remain.

This multicenter pragmatic randomized controlled trial evaluates the effectiveness of AI-assisted LDCT interpretation compared with standard interpretation. Eligible participants will be randomized to an AI-assisted arm or a standard-reading arm. Outcomes include diagnostic accuracy, efficiency, lung cancer incidence, lung cancer mortality, recurrence, and smoking cessation.

The findings will provide evidence on the clinical utility of AI-assisted LDCT screening and support future implementation in routine practice and policy development.

Вмешательства

  • Диагностический тест AI-assisted Low-Dose CT Interpretation
    Participants undergo low-dose computed tomography (LDCT) lung cancer screening. The images are first interpreted by AI-assisted software, which highlights suspicious nodules. Radiologists then review the AI outputs and generate the final report.

Первичные конечные точки

  • Lung Cancer Incidence [Срок оценки: From baseline to 12 months, 36 months, and 60 months.]
  • False Positive Rate [Срок оценки: Within 6 months following LDCT screening.]
Вторичные конечные точки (7)
  • Lung Cancer Mortality [Срок оценки: From baseline to 12 months, 36 months, and 60 months.]
  • Lung Cancer Recurrence Rate [Срок оценки: From baseline to 12 months, 36 months, and 60 months.]
  • All-Cause Mortality [Срок оценки: From baseline to 12 months, 36 months, and 60 months.]
  • Time to Diagnosis [Срок оценки: At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.]
  • Time to Treatment Initiation [Срок оценки: At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.]
  • Follow-up Completion Rate [Срок оценки: Up to 12 months post-screening.]
  • Smoking Cessation Rate [Срок оценки: Assessed at 3 months, 6 months, and 12 months after baseline screening.]

Критерии участия

Критерии включения

  • Family History of Lung Cancer: Males aged 45-74 or females aged 40-74 with first-degree relatives (parents, siblings, or children) diagnosed with lung cancer.
  • Heavy Smoking History: Ages 50-74 with ≥20 pack-years smoking history, currently smoking or quit <15 years ago.
  • General Screening Participants: Adults aged 40 years or older attending routine health check-ups.

Критерии исключения

  • Pregnant women.
  • Chest CT or other higher-radiation chest imaging within the past 12 months.
  • Individuals holding a major illness certificate for lung cancer.
  • Inability to undergo thoracic puncture or surgery.
  • Inability to hold breath or otherwise complete the scanning procedure.
  • Hemoptysis of unknown cause within the past month.
  • Chest X-ray within the past month showing suspicious lung lesions.
  • Unexplained weight loss >6 kg within the past year.
  • History of lung cancer within the past three years.
  • Presence of other severe diseases with an expected life expectancy <5 years.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Скрининг

Центры проведения

Тайвань · 1 центр
  • Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT07280559 · 2025-11-002AU-3AI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗