Идёт набор NCT07421713

A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older

— Наблюдательное Osteoporosis, Osteopenia

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: Osteo Signal.
Кому может быть актуально: Состояния в реестре: Osteoporosis, Osteopenia. Базовые параметры: от 50 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: Нидерланды, Великобритания
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

A Retrospective Multi-centre Paired Accuracy Study to Evaluate the Performance of Osteo Signal Against the Dual-energy X-ray Absorptiometry (DXA) for Opportunistic Osteoporosis Screening.

Обзор

The goal of this study is to assess the performance of an artificial intelligence software (Osteo Signal) in detecting osteoporosis risk in adults 50 years and older. The main question it aims to answer is: What is the accuracy of the software in detecting osteoporosis risk on chest x-ray images as compared to the standard technique of dual-energy x-ray absorptiometry (DXA)? There is no direct involvement of participants in this study as it will use data from individuals who have already had a chest x-ray and a DXA scan taken in the past.

Вмешательства

Устройство Osteo Signal
Artificial Intelligence (AI) software

Первичные конечные точки

Two class bone status classification (osteoporosis/non osteoporosis) [Срок оценки: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other]

Вторичные конечные точки (2)

Three class bone status classification (osteoporosis/osteopenia/normal) [Срок оценки: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other]
Classification for osteoporosis and osteopenia [Срок оценки: At a time following the participant having had a chest x-ray and DXA scan within 6 months of each other]

Критерии участия

Критерии включения

Age ≥50 years at the time of chest X-ray
Availability of

Posteroanterior (PA) Chest X-ray and
DXA scan with a valid T-score measurement where both the DXA scan and Chest x-ray examinations were performed within 6 months (182 days) of each other and
Available X-ray and DXA scans performed on or after 01-Jan-2010.
Complete metadata (sex and age) available on PACS or hospital records.

Критерии исключения

Non-diagnostic Quality or Incomplete Imaging of:

DXA scan inadequacy: Missing T-score from a technically inadequate scan.
PA Chest X-ray technical inadequacy: Non-PA projection, significant motion artefacts, inadequate visualisation of thoracic structures, or missing DICOM metadata.
Image format incompatibility: Non-DICOM format or corrupted image files that would prevent AI analysis
PA Chest X-ray > ±6 months from the date of the DXA scan.
Previous diagnosis or treatment of Osteoporosis prior to the DXA scan used in the Study.

diagnosis of osteoporosis (T-score ≤-2.5), or current/recent anti- osteoporotic medications, within 12 months prior to the DXA scan used in the study.
Current or recent anti-osteoporotic medications for 3 months (91 days) continuously prior to the Chest x-ray used in the Study.
Diagnosis of any metabolic bone disease prior to the DXA scan used in the study.
Diagnosis of metabolic bone disease other than Osteoporosis or Osteopenia, up to a maximum of 3 months (91 days) after the DXA scan.
Major Chest Wall or Spinal Deformities, including but not limited to:

Severe structural deformities: Thoracic scoliosis with Cobb angle >40°, severe kyphosis, or chest wall deformities (pectus excavatum/carinatum) affecting >30% of the thoracic cage.
Surgical hardware: Previous thoracic/spinal surgery with metallic implants obscuring anatomical landmarks required for AI analysis.
Pathological conditions: Extensive pulmonary consolidation, pleural effusion, lesions or masses obscuring >30% of thoracic skeletal structures
Subject has opted out of confidential data being used for research purposes

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

Здоровые добровольцы: Да