Validation of a Deep Learning Tool for Opportunistic Osteoporosis Screening Using Routine Non-Contrast CT Scans

Condition(s) studied

Investigational drug(s) / intervention(s)

DeepBMD model for osteoporosis risk screening: The DeepBMD model is applied to routine chest or abdominal CT scans to identify patients at high risk for osteoporosis. This is a non-invasive image analysis used solely for screening and recruitment purposes, not as a therapeutic intervention.

Study summary

The goal of this clinical trial is to test if an artificial intelligence (AI) tool called DeepBMD can accurately identify people at high risk for osteoporosis using routine chest or abdomen CT scans. The main questions it aims to answer are:

1. Can the DeepBMD tool correctly identify people who have osteoporosis compared to the standard bone density test, dual-energy X-ray absorptiometry (DXA)?
2. Is it practical to use this AI tool in real-world hospital settings to find and contact high-risk patients? Researchers will use the DeepBMD tool to analyze existing CT scans. If the tool flags a patient as high risk, researchers will call them to invite them for a standard bone density test (DXA).

Participants will:

1. Have their existing chest or abdomen CT scan analyzed by the DeepBMD AI tool;
2. Receive a phone call from the research team if identified as high risk;
3. Visit the clinic for a free standard bone density test (DXA) if they agree to participate.

Eligibility

Primary outcome measure(s)

• Diagnostic performance of DeepBMD model for osteoporosis screening — Concurrent with the DXA validation visit following the CT analysis (within 7 days).
  The diagnostic performance of the DeepBMD model will be evaluated by comparing its predictions against the gold standard Dual-energy X-ray Absorptiometry (DXA). Specifically, we will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the Area Under the Receiver Operating Characteristic Curve (AUC) for identifying patients with osteoporosis.

Trial sites (1)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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