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临床试验/NCT06488872
NCT06488872招募中不适用

Comparison of Artificial Intelligence-based Analysis of Computed Tomography Data With Routinely Performed Measurements Concerning Bone and Muscle Health of Aged Individuals to Validate Surrogate Parameters for the Aging Population.

University Department of Geriatric Medicine FELIX PLATTER1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Muscle Volume in mm3 on CT

研究概览

简要总结

This study focuses on researching sarcopenia and bone loss (osteoporosis), aiming to develop early and effective methods for diagnosis and treatment. These health issues significantly contribute to falls, fractures, and loss of independence and quality of life in old age, particularly affecting individuals impairments. To address these challenges, the study employs innovative imaging techniques based on artificial intelligence (AI) to accurately assess age-related muscle atrophy. A central approach is to analyze existing computed tomography (CT) images of older adults, using retrospective data to evaluate muscle quality. This method aims to efficiently assess muscle quality without additional resources. AI algorithms analyze fine details of muscle tissue, such as muscle adiposity and density. The algorithm can detect fat content within muscles, which negatively impacts muscle health and functionality, and identify irregularities or abnormalities in muscle fibers. This non-invasive approach is crucial for early detection of muscle atrophy and monitoring treatment success. Integrating AI technologies advances beyond conventional imaging techniques, allowing precise analysis of muscle quality. This method not only offers efficient diagnosis and monitoring of sarcopenia but also opens new avenues for personalized therapeutic approaches and improved patient care. Almost every elderly person has at least one existing CT scan, a common and excellent method of medical imaging for significant health issues. These images can be retrospectively analyzed for muscle health. In addition to imaging techniques, the study includes functional tests such as hand strength and walking speed measurements to assess muscle health and condition. These tests establish objective quality characteristics of muscles and assess the effectiveness of prevention and treatment measures. This research aims to provide early diagnosis and effective treatment strategies for sarcopenia and osteoporosis, ultimately improving the quality of life for the elderly. By leveraging AI and existing medical imaging data, the study promotes efficient, sustainable, and precise healthcare solutions for age-related muscle and bone deterioration.

详细描述

Age-related muscle wasting and bone loss are significant public health challenges impacting elderly mobility and independence. Sarcopenia, a decline in muscle strength and mass, heightens fall risk, particularly in individuals with dementia or cognitive impairments. This leads to complications, reduced independence, and diminished quality of life. Osteoporosis increases the risk of fractures from falls or spontaneously, necessitating early diagnosis and prevention.

Despite effective treatments for sarcopenia, such as a protein-rich diet and strength training, the condition remains underrecognized due to diagnostic challenges. Common methods like hand strength measurement are problematic for those with rheumatic conditions or Parkinson's, often yielding inaccurate results. Other methods, like measuring leg strength and walking speed, require coordination and balance, which can be difficult for those with dementia or visual impairments. There is a need for tailored diagnostic solutions for diverse aging populations.

Bone mineral density (BMD) is crucial for assessing health in older adults, as low BMD indicates osteoporosis and a higher fracture risk. Traditionally measured by dual X-ray absorptiometry (DEXA), BMD assessment can be difficult for patients with mobility issues, pressure ulcers, or dementia due to the requirement to remain still for extended periods.

New AI-based algorithms can now automatically evaluate body tissues and patterns from routine CT scans, offering reproducible results beyond human capability. AI can quantify muscle mass at specific body cross-sections, such as lumbar vertebral point 3 (L3), which correlates with total body muscle mass and predicts muscle health. CT measurements of thigh and psoas muscles can also indicate whole body skeletal muscle mass. European guidelines highlight the need for muscle quantification in early sarcopenia diagnosis.

Correlating AI-measured muscle mass with functional muscle strength assessments can help identify surrogate parameters for early sarcopenia detection. Additionally, measuring muscle fat content, which correlates with strength loss, is essential for assessing muscle health. Innovative approaches are required, as sarcopenia diagnosis is still evolving and geriatric diseases often need proportionate diagnostic and treatment strategies due to multiple comorbidities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • CT examination (thorax, abdomen, pelvis, spine with muscle parts to be visualized) by the responsible in-house radiology department one month before or after the inpatient stay at the UAFP (sarcopenia arm).
  • CT thorax and CT abdomen images of patients from the responsible in-house radiology department and an in-house DEXA measurement. Both examinations may be performed no more than 18 months apart (osteoporosis arm).
  • Diagnostic image quality of CT scans.

排除标准

  • Presence of a documented refusal.
  • Non-diagnostic image quality
  • Absence of the following functional measurements: Hand strength on both hands, timed-up & go test, gait speed.

结局指标

主要结局

Muscle Volume in mm3 on CT

时间窗: through study completion, an average o 1 year

Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating muscle volume (in mm3) on CT.

bone density/attenuation in HU on CT.

时间窗: through study completion, an average o 1 year

Analysis of bone density/attenuation in HU on CT to evaluate the primary endpoint Osteoporosis:

fat percentage in muscle density (in HU) on CT.

时间窗: through study completion, an average o 1 year

Exploratory analysis of quantitative variables that can be determined by CT to evaluate the primary endpoint Sarcopenia: By evaluating fat percentage in muscle density (in HU) on CT.

次要结局

未报告次要终点

研究者

发起方
University Department of Geriatric Medicine FELIX PLATTER
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Fischer

PD Dr.med. Andreas M. Fischer, Principal Investigator, Head of NutriCare Clinic

University Department of Geriatric Medicine FELIX PLATTER

研究点 (1)

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