- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04959656
Multimodal Imaging-assisted Diagnosis Model for Cervical Spine Tumors
Based on a Small Sample Deep Learning Multi-modal Image-assisted Diagnosis Model of Cervical Spine Tumors Clinical Application Research
Cervical spine tumor is a small sample of tumor disease with low incidence, great harm, and complex anatomical structure. It is very difficult to identify and classify benign and malignant cervical spine tumors clinically.
The deep learning model we constructed in the early stage has a higher accuracy rate for the image diagnosis of cervical spondylosis with a large number of cases, and a better clinical application effect, but the accuracy rate for cervical spine tumors with a small number of cases is lower. The reason may be the amount of data. With limited tasks, the traditional deep learning model is difficult to play an effective role.
Based on this, we propose to build a small sample-oriented deep learning model to assist clinicians in the diagnosis of cervical spine tumors with multimodal images, and to evaluate the benign and malignant tumors.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-50 years old, about 300 males and females; in the orthopedics outpatient and emergency department of our hospital, the imaging scans (X-ray, CT, MR) showed no obvious abnormalities.
Exclusion Criteria:
- have had surgery before acquiring the images, Those who have cervical spine fractures, deformities, infections, etc. who cannot cooperate with imaging examinations, and those who have not signed the informed consent. The normal control group" includes about 600 patients with normal or slightly degenerated cervical spine, as a standard for training computers to recognize cervical spine structures Images and control images for detecting tumor lesions.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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X-ray
This study completed the manual labeling of preoperative multi-modal images of cervical spine structures and tumor lesions.
On the normal cervical spine, six target areas were labeled: cervical spinal cord (MRI), cervical spine alignment (MRI), cervical intervertebral discs ( MRI), cervical spinal canal area (MRI), cervical cobb angle (X-ray) and cervical posterior longitudinal ligament ossification (CT).
For cervical tumor lesions, complete MR and CT as well as orthopedic, axial and coronal positions.
The label on the lateral X-ray image.
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CT
This study completed the manual labeling of preoperative multi-modal images of cervical spine structures and tumor lesions.
On the normal cervical spine, six target areas were labeled: cervical spinal cord (MRI), cervical spine alignment (MRI), cervical intervertebral discs ( MRI), cervical spinal canal area (MRI), cervical cobb angle (X-ray) and cervical posterior longitudinal ligament ossification (CT).
For cervical tumor lesions, complete MR and CT as well as orthopedic, axial and coronal positions.
The label on the lateral X-ray image.
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|
MRI
This study completed the manual labeling of preoperative multi-modal images of cervical spine structures and tumor lesions.
On the normal cervical spine, six target areas were labeled: cervical spinal cord (MRI), cervical spine alignment (MRI), cervical intervertebral discs ( MRI), cervical spinal canal area (MRI), cervical cobb angle (X-ray) and cervical posterior longitudinal ligament ossification (CT).
For cervical tumor lesions, complete MR and CT as well as orthopedic, axial and coronal positions.
The label on the lateral X-ray image.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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tumor detection
Time Frame: 2022-2023
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On the basis of the cervical spine structure, it is the modeling of the tumor.
The model based on weakly supervised learning recognizes the morphological features such as the size of the tumor lesion, and uses the fast-adapted meta-learning method to achieve a fast model under a small amount of training.
Optimize, and finally evaluate the benignity, borderline and malignant probability of the tumor and use it as an output.
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2022-2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cervical spine detection
Time Frame: 2022-2023
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Taking the postoperative pathology report of cancer patients as the audit standard, testing the sensitivity and accuracy of the model, and integrating it into a complete deep learning model.
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2022-2023
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: hanqiang ouyang, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00006761-M2020255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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