Validation of a Deep Learning Tool for Opportunistic Osteoporosis Screening Using Routine Non-Contrast CT Scans
1. september 2026 oppdatert 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic performance of DeepBMD model for osteoporosis screening
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of the DeepBMD screening and recall workflow
Tidsramme: 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.
|
At the end of recruitment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Fan Yang, PhD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. juli 2026
Primær fullføring (Faktiske)
28. august 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
22. juli 2026
Først innsendt som oppfylte QC-kriteriene
27. juli 2026
Først lagt ut (Faktiske)
31. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UHCT260668
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data will be available beginning 3 months following article publication and ending 36 months following article publication.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .