- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239638
Analysis of Cervical Spinal MRI With Deep Learning
July 19, 2022 updated by: Bezmialem Vakif University
The aim of this study is analyzing the pathologies in cervical spinal MRI images by using image processing algorithms.
Determination of these pathological cases which taught to the system with deep learning and determination of their levels.
Finally; verification of the system by comparing radiologist reports and automated system outputs.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Neck pain is a very common health problem with a worldwide prevalence ranging from 16.7% to 75.1%.
The source of neck pain is often considered - although there is no strong evidence - the cervical intervertebral disc.
Radiological imaging methods are used for the detection of degeneration of the discs and the end plaque changes in the vertebral body corresponding to this degeneration.Magnetic Resonance Imaging (MRI) gives information about the structure of intervertebral disc, width of spinal canal and tissues outside the canal.
However, there is no standardization in the identification and evaluation of radiological images, and interobserver variability is high.
Studies have been initiated on automated systems that analyze MRI images to increase the accuracy and consistency of reporting procedures.
Examining MRI images with deep learning can lead to the production of systems that help clinical decision making and also allows the evaluation of large data in a short time.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Bezmialem Vakif University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with neck pain between 18-75 years
Description
Inclusion Criteria:
- 18-75 years of age
- Having result of a cervical spinal MRI, which was performed for neck pain in the hospital records in the last 5 years.
Exclusion Criteria:
- Malignancy
- Signs of active infection
- Significant spinal vertebral deformity (advanced scoliosis, congenital vertebral defects)
- Spinal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy rate of the model as assessed by cross validation of the data set
Time Frame: Through study completion, an average of 1,5 years
|
We will randomly divide the dataset into 4 subsets.
In each sub-experiments, MRI slices from 3 subsets will be trained and slices in the other subset will be tested.
We will perform totally 4 sub-experiments, so each slice in the dataset will be tested once.
|
Through study completion, an average of 1,5 years
|
Reliability of the model as assessed by comparing the reports of the model and radiologist.
Time Frame: Through study completion, an average of 1,5 years
|
Kappa statistics and reliability coefficients will be use.
|
Through study completion, an average of 1,5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Castro-Mateos I, Hua R, Pozo JM, Lazary A, Frangi AF. Intervertebral disc classification by its degree of degeneration from T2-weighted magnetic resonance images. Eur Spine J. 2016 Sep;25(9):2721-7. doi: 10.1007/s00586-016-4654-6. Epub 2016 Jul 7.
- Jamaludin A, Lootus M, Kadir T, Zisserman A, Urban J, Battie MC, Fairbank J, McCall I; Genodisc Consortium. ISSLS PRIZE IN BIOENGINEERING SCIENCE 2017: Automation of reading of radiological features from magnetic resonance images (MRIs) of the lumbar spine without human intervention is comparable with an expert radiologist. Eur Spine J. 2017 May;26(5):1374-1383. doi: 10.1007/s00586-017-4956-3. Epub 2017 Feb 6.
- Kim S, Bae WC, Masuda K, Chung CB, Hwang D. Fine-Grain Segmentation of the Intervertebral Discs from MR Spine Images Using Deep Convolutional Neural Networks: BSU-Net. Appl Sci (Basel). 2018 Sep;8(9):1656. doi: 10.3390/app8091656. Epub 2018 Sep 14.
- Daenzer S, Freitag S, von Sachsen S, Steinke H, Groll M, Meixensberger J, Leimert M. VolHOG: a volumetric object recognition approach based on bivariate histograms of oriented gradients for vertebra detection in cervical spine MRI. Med Phys. 2014 Aug;41(8):082305. doi: 10.1118/1.4890587.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
April 1, 2022
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 20, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54022451
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Disc Disease
-
Assiut UniversityUnknownCervical Disc Disease | Cervical Disc Herniation | Cervical Disc Degeneration
-
Research SourceEnrolling by invitationCervical Disc DiseaseUnited States
-
Ataturk UniversityCompleted
-
NYU Langone HealthCompleted
-
Synthes USA HQ, Inc.CompletedSymptomatic Cervical Disc Disease
-
Providence Medical Technology, Inc.WithdrawnCervical Radiculopathy | Cervical Spondylosis | Cervical Degenerative Disc DiseaseUnited States
-
Xijing HospitalUnknownSymptomatic Cervical Disc Disease
-
Medtronic Spinal and BiologicsCompletedDegenerative Cervical Disc DiseaseSaudi Arabia, Greece, Serbia, Hungary, Czech Republic, Kuwait, Poland, Slovakia
-
NuVasiveEnrolling by invitationDegenerative Disc Disease | Cervical Disc DiseaseUnited States
-
LDR Spine USACompletedCervical Disc Disease | Cervical Disc DegenerationUnited States
Clinical Trials on Cervical Spinal MRI
-
Bragee ClinicsNot yet recruitingChronic Fatigue Syndrome
-
Loma Linda UniversityCompleted
-
Seoul National University HospitalCompletedLow Back Pain | Cervical Myelopathy SpondylosisKorea, Republic of
-
Hacettepe UniversityBElibol; NKöse; GYÇakmaklı; SAksoy; RGöçmenCompletedParkinson DiseaseTurkey
-
Canadian Memorial Chiropractic CollegeUniversity of GuelphCompletedMyofascial Pain Syndrome | Myofascial Trigger Points | Trigger Points, MyofascialCanada
-
University Hospital, Clermont-FerrandCompletedCIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) | CMT (Charcot Marie Tooth Disease)France
-
K2M, Inc.Recruiting
-
National University of Health SciencesAuburn University; Canadian Memorial Chiropractic CollegeCompleted
-
University of LouisvilleWithdrawnSpinal Cord InjuriesUnited States
-
Charitable Foundation Children with Spinal Muscular...WithdrawnSpinal Muscular Atrophy | Neuromuscular DisordersUkraine