- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04958408
Deep Learning of Knee Joint MRI Intelligent Detection
8 de julio de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Anticipado)
50000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jia-Kuo Yu
- Número de teléfono: 01082267392
- Correo electrónico: yujiakuo@126.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100191
- Reclutamiento
- Institute of Sports Medicine, Peking University Third Hospital
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Contacto:
- Ai-Bing Huang, PhD
- Número de teléfono: 8615650715003
- Correo electrónico: hab165@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
All patients related to sports injuries
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Marking system design based on Magnetic Resonance Imaging(MRI)
Periodo de tiempo: 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.
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2021
|
Data export and annotation
Periodo de tiempo: 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.
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2021
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Build a deep learning model
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2021
Finalización primaria (Anticipado)
31 de diciembre de 2021
Finalización del estudio (Anticipado)
15 de mayo de 2022
Fechas de registro del estudio
Enviado por primera vez
27 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
8 de julio de 2021
Publicado por primera vez (Actual)
12 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de julio de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M2020243
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .