Artificial IntelligenceNCT04952233
Application Value of Deep Learning in Diagnosis of Cervical Spondylosis
An observational study of Artificial Intelligence, run by Peking University Third Hospital at 1 site in China.
Trial summary
Compared with the personal experience judgment of physicians, deep learning can identify something more quickly, efficiently, and accurately The identification and diagnosis of diseases save the energy of clinical and imaging doctors and achieve an individualized diagnosis of patients Diagnosis and evaluation are… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2021to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age 18 to 80 years old, no surgical treatment before imaging scan; Patients with cervical spondylosis confirmed by imaging report and clinical diagnosis and patients with cervical vertebra imaging CT without any obvious abnormality.
Who may be able to join
- No surgical treatment was performed before the imaging scan. Imaging report and clinical diagnosis of cervical spondylosis with or without ossification of the posterior longitudinal ligament.
- Patients who visited the orthopedics department and emergency department of our hospital without any surgical treatment before image scan and no obvious abnormalities were found in cervical imaging CT.
Who cannot join
- Surgery before image data acquisition;
- Cervical cancer, tuberculosis, and fracture;
- The lack of image data, the image is not clear.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 010
Huishu Yuan, Dr, 13521627288, huishuy@bjmu.edu.cn
About this study
Compared with the personal experience judgment of physicians, deep learning can identify something more quickly, efficiently, and accurately The identification and diagnosis of diseases save the energy of clinical and imaging doctors and achieve an individualized diagnosis of patients Diagnosis and evaluation are beneficial to the formulation of clinical surgical methods and the improvement of patients' prognoses.
This study uses deep learning technology, through the big data of cervical spondylosis cases learn, to explore the use of deep learning The feasibility of identifying and analyzing the characteristic imaging findings of cervical CT images that may be suggestive of a diagnosis It is attempted to reach the level of artificial intelligence-assisted diagnosis of cervical spondylosis.
Read the detailed description
Cervical spondylosis is due to cervical discs and intervertebral joints and their secondary changes to the adjacent spinal cord, nerve roots, and vertebrae Artery and other tissue structure, causing the corresponding clinical symptoms. Cervical spondylosis is a common and frequent disease among middle-aged and elderly people. The incidence of cervical spondylosis is 10 percent in people over 30 years of age and is higher among those who work at a desk.
Two kinds of cervical spondylosis are common: cervical spondylotic radiculopathy and cervical spondylotic myelopathy. The principles of treatment differ greatly, and the prognosis after treatment is also different. Precise preoperative imaging and clinical diagnosis are helpful to accurately estimate the effect of surgery and the prognosis of patients.
Therefore, to achieve early accurate diagnosis is to improve the cervical spine Key to the curative effect of the disease. Generally referred to as deep learning is a kind of pattern analysis method, through the combination of simple and nonlinear module for multi-level "character learning" or "said learning" model of each module to each layer (original input) data into a higher dimension, more abstract representation, when there are enough of these transformations, The initial "low level" feature representation can be transformed into "high level" feature representation, and complex learning tasks such as classification can be completed.
For the classification task, the features that are important to the classification are amplified by increasing the number of layers, and the irrelevant features are ignored.
At present, the main research methods include Convolutional Neural Networks (CNN), self-coding Neural Networks based on multi-layer neurons, and deep confidence Networks. At present, CNN is mainly used in the field of medical image recognition.
Such as AlexNet, Densenet, VGG16, Googlenet and so on. The motivation for deep learning is to build neural networks that mimic the human brain for analytical learning. It imitates the mechanisms of the human brain to interpret data, such as images, sounds, and text and has made significant progress in solving many problems that are difficult for traditional machine learning to solve.
Deep learning methods have proven to be very good at discovering complex structures in high-dimensional data.
In the field of medical and health care, artificial intelligence technology has gradually solved the problem of data interpretation of various medical images, discovered more information "hidden" behind the images, such as X-ray, CT, MRI, etc., and will gradually realize the recognition, screening, and diagnosis of a specific case, reaching the expert level of diagnosis.
At the same time, the application of artificial intelligence technology can reduce the load of doctors, reduce medical misdiagnosis, and improve the efficiency of diagnosis and treatment.
At present, deep learning has been widely used in the diagnosis and prediction of various diseases in various systems of the body.
Hemke et al. conducted machine learning research after manual segmentation of pelvic CT images and found that the deep learning model can be used to automatically recognize and segment a variety of different types of tissues in the pelvic cavity, including muscle, bone, fat, subcutaneous adipose tissue, etc.
Koichiro Yasaka et al. [8] conducted a deep learning study on the lumbar spine and found that deep learning can be used to predict the bone density of the lumbar spine and further evaluate the severity of osteoporosis.
Spampinato et al. conducted a deep learning study on hand X-rays to predict bone age.
Therefore, it is of great significance to apply deep learning, an emerging analytical technique, to the recognition of imaging features of cervical CT images. The research significance is as follows:
Accurate and efficient preoperative diagnosis of cervical spondylosis can be realized to avoid excessive medical treatment or disease delay caused by missed diagnosis and misdiagnosis. Individualized diagnosis and evaluation can be achieved for patients, which helps clinically to reasonably specify treatment strategies, and is conducive to the formulation of clinical surgical methods and the improvement of patient prognosis.
- Conditions
- Artificial Intelligence
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the consistency between AI and clinicians in identifying cervical CT features (cervical curvature, alignment, intervertebral space, disc herniation, ossification of the posterior longitudinal ligament, spinal stenosis)
Compare the consistency between AI and clinicians in identifying cervical CT features (cervical curvature, alignment, intervertebral space, disc herniation, ossification of the posterior longitudinal ligament, spinal stenosis)
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start30 Jan 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- huishu yuan, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952233
- Sponsor's protocol ID
- M2020499
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Deep Learning in Diagnosis of Cervical Spondylosis
- ClinicalTrials.gov ID
- NCT04952233
- Acronym / sponsor ID
- M2020499
- Conditions
- Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared with the personal experience judgment of physicians, deep learning can identify something more quickly, efficiently, and accurately The identification and diagnosis of diseases save the energy of clinical and imaging doctors and achieve an individualized diagnosis of patients Diagnosis and evaluation are beneficial to the formulation of clinical surgical methods and the improvement of patients' prognoses.
This study uses deep learning technology, through the big data of cervical spondylosis cases learn, to explore the use of deep learning The feasibility of identifying and analyzing the characteristic imaging findings of cervical CT images that may be suggestive of a diagnosis It is attempted to reach the level of artificial intelligence-assisted diagnosis of cervical spondylosis.
Detailed description
Cervical spondylosis is due to cervical discs and intervertebral joints and their secondary changes to the adjacent spinal cord, nerve roots, and vertebrae Artery and other tissue structure, causing the corresponding clinical symptoms. Cervical spondylosis is a common and frequent disease among middle-aged and elderly people. The incidence of cervical spondylosis is 10 percent in people over 30 years of age and is higher among those who work at a desk.
Two kinds of cervical spondylosis are common: cervical spondylotic radiculopathy and cervical spondylotic myelopathy. The principles of treatment differ greatly, and the prognosis after treatment is also different. Precise preoperative imaging and clinical diagnosis are helpful to accurately estimate the effect of surgery and the prognosis of patients.
Therefore, to achieve early accurate diagnosis is to improve the cervical spine Key to the curative effect of the disease. Generally referred to as deep learning is a kind of pattern analysis method, through the combination of simple and nonlinear module for multi-level "character learning" or "said learning" model of each module to each layer (original input) data into a higher dimension, more abstract representation, when there are enough of these transformations, The initial "low level" feature representation can be transformed into "high level" feature representation, and complex learning tasks such as classification can be completed.
For the classification task, the features that are important to the classification are amplified by increasing the number of layers, and the irrelevant features are ignored.
At present, the main research methods include Convolutional Neural Networks (CNN), self-coding Neural Networks based on multi-layer neurons, and deep confidence Networks. At present, CNN is mainly used in the field of medical image recognition.
Such as AlexNet, Densenet, VGG16, Googlenet and so on. The motivation for deep learning is to build neural networks that mimic the human brain for analytical learning. It imitates the mechanisms of the human brain to interpret data, such as images, sounds, and text and has made significant progress in solving many problems that are difficult for traditional machine learning to solve.
Deep learning methods have proven to be very good at discovering complex structures in high-dimensional data.
In the field of medical and health care, artificial intelligence technology has gradually solved the problem of data interpretation of various medical images, discovered more information "hidden" behind the images, such as X-ray, CT, MRI, etc., and will gradually realize the recognition, screening, and diagnosis of a specific case, reaching the expert level of diagnosis.
At the same time, the application of artificial intelligence technology can reduce the load of doctors, reduce medical misdiagnosis, and improve the efficiency of diagnosis and treatment.
At present, deep learning has been widely used in the diagnosis and prediction of various diseases in various systems of the body.
Hemke et al. conducted machine learning research after manual segmentation of pelvic CT images and found that the deep learning model can be used to automatically recognize and segment a variety of different types of tissues in the pelvic cavity, including muscle, bone, fat, subcutaneous adipose tissue, etc.
Koichiro Yasaka et al. [8] conducted a deep learning study on the lumbar spine and found that deep learning can be used to predict the bone density of the lumbar spine and further evaluate the severity of osteoporosis.
Spampinato et al. conducted a deep learning study on hand X-rays to predict bone age.
Therefore, it is of great significance to apply deep learning, an emerging analytical technique, to the recognition of imaging features of cervical CT images. The research significance is as follows:
Accurate and efficient preoperative diagnosis of cervical spondylosis can be realized to avoid excessive medical treatment or disease delay caused by missed diagnosis and misdiagnosis. Individualized diagnosis and evaluation can be achieved for patients, which helps clinically to reasonably specify treatment strategies, and is conducive to the formulation of clinical surgical methods and the improvement of patient prognosis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 to 80 years old, no surgical treatment before imaging scan; Patients with cervical spondylosis confirmed by imaging report and clinical diagnosis and patients with cervical vertebra imaging CT without any obvious abnormality.
Key inclusion criteria (2 listed)
- No surgical treatment was performed before the imaging scan. Imaging report and clinical diagnosis of cervical spondylosis with or without ossification of the posterior longitudinal ligament.
- Patients who visited the orthopedics department and emergency department of our hospital without any surgical treatment before image scan and no obvious abnormalities were found in cervical imaging CT.
Key exclusion criteria (3 listed)
- Surgery before image data acquisition;
- Cervical cancer, tuberculosis, and fracture;
- The lack of image data, the image is not clear.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the consistency between AI and clinicians in identifying cervical CT features (cervical curvature, alignment, intervertebral space, disc herniation, ossification of the posterior longitudinal ligament, spinal stenosis)
Time frame: 2019-2021
Compare the consistency between AI and clinicians in identifying cervical CT features (cervical curvature, alignment, intervertebral space, disc herniation, ossification of the posterior longitudinal ligament, spinal stenosis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
huishu yuan study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artificial Intelligence, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huishu yuan (13521627288, chunjiewang17@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the consistency between AI and clinicians in identifying cervical CT features (cervical curvature, alignment, intervertebral space, disc herniation, ossification of the posterior longitudinal ligament, spinal stenosis) (time frame: 2019-2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.