Validation of a Deep Learning Tool for Opportunistic Osteoporosis Screening Using Routine Non-Contrast CT Scans
1 september 2026 uppdaterad av: Yang Fan, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Prospective Clinical Validation Study of a Deep Learning Model for Opportunistic Osteoporosis Screening Based on Non-Contrast CT Scans
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:
- Can the DeepBMD tool correctly identify people who have osteoporosis compared to the standard bone density test, dual-energy X-ray absorptiometry (DXA)?
- 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:
- Have their existing chest or abdomen CT scan analyzed by the DeepBMD AI tool;
- Receive a phone call from the research team if identified as high risk;
- Visit the clinic for a free standard bone density test (DXA) if they agree to participate.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
100
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients who underwent non-contrast CT at our hospital (Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) and were identified as high-risk for osteoporosis by the DeepBMD model.
Beskrivning
Inclusion Criteria:
- Underwent non-contrast CT at our institution, with qualified image quality and no severe artifacts;
- Identified as high-risk for osteoporosis by the DeepBMD model;
- Had valid contact information available in the PACS, possessed normal cognitive and communication abilities, and was able to cooperate with telephone follow-ups and on-site examinations;
- Voluntarily participated in the study, was able to sign a written informed consent form on-site, and agreed to undergo DXA examination.
Exclusion Criteria:
- Severe spinal deformity, postoperative spinal internal fixation, malignant bone metastasis, or severe osteolytic lesions that may interfere with measurements;
- A confirmed diagnosis of osteoporosis with ongoing standardized treatment;
- Inability to be contacted, explicit refusal of follow-up, or inability to visit the hospital for informed consent signing and DXA examination.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
High-risk patients for osteoporosis identified by DeepBMD model
Patients who underwent routine chest or abdominal CT scans and were identified as high risk for osteoporosis by the DeepBMD AI model.
These participants will be contacted via telephone, invited to the clinic, and undergo a free DXA scan to verify bone mineral density.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic performance of DeepBMD model for osteoporosis screening
Tidsram: 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.
|
Concurrent with the DXA validation visit following the CT analysis (within 7 days).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility of the DeepBMD screening and recall workflow
Tidsram: At the end of recruitment
|
It will be assessed by calculating the proportion of patients identified as high-risk by DeepBMD who successfully complete the telephone follow-up and undergo the confirmatory DXA scan within the scheduled timeframe.
We will also record the reasons for refusal or loss to follow-up to evaluate the acceptability of this AI-driven screening pathway.
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At the end of recruitment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Fan Yang, PhD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Jang S, Graffy PM, Ziemlewicz TJ, Lee SJ, Summers RM, Pickhardt PJ. Opportunistic Osteoporosis Screening at Routine Abdominal and Thoracic CT: Normative L1 Trabecular Attenuation Values in More than 20 000 Adults. Radiology. 2019 May;291(2):360-367. doi: 10.1148/radiol.2019181648. Epub 2019 Mar 26.
- Wang P, She W, Mao Z, Zhou X, Li Y, Niu J, Jiang M, Huang G. Use of routine computed tomography scans for detecting osteoporosis in thoracolumbar vertebral bodies. Skeletal Radiol. 2021 Feb;50(2):371-379. doi: 10.1007/s00256-020-03573-y. Epub 2020 Aug 7.
- Smith AD. Screening of Bone Density at CT: An Overlooked Opportunity. Radiology. 2019 May;291(2):368-369. doi: 10.1148/radiol.2019190434. Epub 2019 Mar 26. No abstract available.
- Zeng Q, Li N, Wang Q, Feng J, Sun D, Zhang Q, Huang J, Wen Q, Hu R, Wang L, Ma Y, Fu X, Dong S, Cheng X. The Prevalence of Osteoporosis in China, a Nationwide, Multicenter DXA Survey. J Bone Miner Res. 2019 Oct;34(10):1789-1797. doi: 10.1002/jbmr.3757. Epub 2019 Aug 29.
- Cheng X, Zhao K, Zha X, Du X, Li Y, Chen S, Wu Y, Li S, Lu Y, Zhang Y, Xiao X, Li Y, Ma X, Gong X, Chen W, Yang Y, Jiao J, Chen B, Lv Y, Gao J, Hong G, Pan Y, Yan Y, Qi H, Ran L, Zhai J, Wang L, Li K, Fu H, Wu J, Liu S, Blake GM, Pickhardt PJ, Ma Y, Fu X, Dong S, Zeng Q, Guo Z, Hind K, Engelke K, Tian W; China Health Big Data (China Biobank) project investigators. Opportunistic Screening Using Low-Dose CT and the Prevalence of Osteoporosis in China: A Nationwide, Multicenter Study. J Bone Miner Res. 2021 Mar;36(3):427-435. doi: 10.1002/jbmr.4187. Epub 2020 Nov 4.
- Lin X, Xiong D, Peng YQ, Sheng ZF, Wu XY, Wu XP, Wu F, Yuan LQ, Liao EY. Epidemiology and management of osteoporosis in the People's Republic of China: current perspectives. Clin Interv Aging. 2015 Jun 25;10:1017-33. doi: 10.2147/CIA.S54613. eCollection 2015.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 juli 2026
Primärt slutförande (Faktisk)
28 augusti 2026
Avslutad studie (Beräknad)
1 september 2026
Studieregistreringsdatum
Först inskickad
22 juli 2026
Först inskickad som uppfyllde QC-kriterierna
27 juli 2026
Första postat (Faktisk)
31 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UHCT260668
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
De-identified individual participant data (IPD) will be made available to researchers who provide a methodologically sound proposal.
The shared data will include the demographic information, DeepBMD screening results, and confirmatory DXA T-scores used in the study analyses.
Requests should be directed to the corresponding author via email.
Data will be available for non-commercial academic research purposes only.
Applicants must sign a data access agreement prior to receiving the data.
Tidsram för IPD-delning
Data will be available beginning 3 months following article publication and ending 36 months following article publication.
Kriterier för IPD Sharing Access
Researchers who provide a methodologically sound proposal for specific research questions related to osteoporosis screening or AI diagnostics will be granted access.
Approved researchers will have access to the de-identified dataset containing patient demographics, imaging analysis results, and clinical outcomes.
Access will be granted via secure email transfer after signing a data use agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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