- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04958408
Deep Learning of Knee Joint MRI Intelligent Detection
8 juillet 2021 mis à jour par: Peking University Third Hospital
Knee joint is the most common part of sports injury.
MRI is a powerful tool to diagnose knee joint injury.
However, it takes a long time to read the film, needs a lot, and some hidden injuries have a high rate of missed diagnosis.
The emerging deep learning technology can establish automatic recognition model through large samples.
A large sample of knee joint MRI was collected retrospectively to train the deep learning model of knee joint MRI, and the sensitivity and specificity of the deep learning model were verified in multi center.
Depending on the clinical needs, the deep learning model annotation system is established.
A large number of knee MRI were obtained and labeled.
According to the knee joint MRI training depth learning model, and iterative optimization, the final version is formed.
Multi center validation was carried out.
Continuous operation records and corresponding preoperative knee MRI were obtained from multiple hospitals.
The sensitivity and specificity of the model were calculated with operation records as the gold standard.
At the same time, an expert team composed of senior radiologists and sports medicine doctors was organized to read the films.
The sensitivity and specificity of manual reading and AI reading were compared to prove the superiority of AI reading.
This study can improve the efficiency of clinical MRI film reading, reduce the workload of doctors, improve the film reading level of grass-roots hospitals, promote the development of the discipline, and has good social benefits and market prospects.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
The knee joint is the most common sports injury site in the human body, including ligament rupture, meniscus tear, cartilage lesions, and free body formation.
Knee MRI has extremely high sensitivity and specificity in diagnosing knee diseases, especially its negative predictive value is close to 100%, and it is an effective means to assist clinicians in diagnosing knee diseases.
However, there are many MRI sequences of the knee joint, and different diseases have different imaging effects on various sequences, and the types of knee joint diseases are complicated, so it takes a long time to evaluate the knee joint MRI.
Due to the huge clinical demand for knee MRI, it has caused a great burden on radiology and sports medicine orthopedics.
At the same time, for some special injuries of the knee joint, such as hidden meniscus tear, rupture of the anterior cross part and adhesion in place after rupture, local ligament injury, etc., the conclusions given by different readers are very different, and it is easy to miss the diagnosis.
And the missed diagnosis seriously affects the prognosis of the knee joint, leading to the progression of arthritis.
In addition, professional musculoskeletal system imaging experts have a long training cycle, and a large number of orthopedic doctors and radiologists in basic hospitals have limited reading skills for knee MRI, which limits the development of local sports medicine disciplines and the development of related diagnosis and treatment.
The purpose of our research is to train the deep learning model of knee MRI through multi-center and large sample of knee MRI; Multi-center verification of the sensitivity and specificity of the knee MRI deep learning model, and compare the accuracy of the deep learning model and manual image reading.
Type d'étude
Observationnel
Inscription (Anticipé)
50000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jia-Kuo Yu
- Numéro de téléphone: 01082267392
- E-mail: yujiakuo@126.com
Lieux d'étude
-
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Beijing
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Beijing, Beijing, Chine, 100191
- Recrutement
- Institute of Sports Medicine, Peking University Third Hospital
-
Contact:
- Ai-Bing Huang, PhD
- Numéro de téléphone: 8615650715003
- E-mail: hab165@163.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
N/A
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
All patients related to sports injuries
La description
Inclusion Criteria:
- ACL-injured patients;
- Follow-up of patients after ACL injury;
- patients with genetic predisposition to ACL injury;
Exclusion Criteria:
- Patients with joint injury caused by clear external forces;
- Definitely have stroke, heart disease, epilepsy, cranial neurosurgery, migraine;
- Have had a concussion or head injury in the past 6 months.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Marking system design based on Magnetic Resonance Imaging(MRI)
Délai: 2021
|
According to the development goals, combined with the performance of MRI and the structure of the model algorithm, the labeling rules and logic of knee MRI are determined.
On this basis, a labeling system is designed, and different labeling tools are designed for a variety of lesions.
|
2021
|
|
Data export and annotation
Délai: 2021
|
Encrypt the MRI file and import it into the medical standard intelligent labeling system.
Create a dedicated tagging account for each tagger to tag.
Based on the previously marked image data, develop algorithms for segmenting different lesion areas.
|
2021
|
|
Build a deep learning model
Délai: 2021
|
According to the diagnostic logic, we select the coronal and sagittal images of the knee joint T2 MRI sequence for analysis.
And choose the Resnext model that has been verified by a large number of ImageNet and other large data sets to extract the features of the coronal out-of-state images.
After the multi-layer convolution operation, the key feature representation of the image is extracted.
At the same time, in the process of feature extraction, the batch normalization module is used to perform feature transformation to highlight the most meaningful part of the feature.
|
2021
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2021
Achèvement primaire (Anticipé)
31 décembre 2021
Achèvement de l'étude (Anticipé)
15 mai 2022
Dates d'inscription aux études
Première soumission
27 juin 2021
Première soumission répondant aux critères de contrôle qualité
8 juillet 2021
Première publication (Réel)
12 juillet 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juillet 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M2020243
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .