Cervical Spondylotic MyelopathyNCT04955041
Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylotic Myelopathy, run by Peking University Third Hospital.
Trial summary
Utilization of T2* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- MRI
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients came from Peking University Third Hospital
Who may be able to join
- diagnosed with CSM and operated on by one senior orthopedist
- available preoperative MRI results
- high-quality image data with no motion artifacts
- available preoperative and long-term follow-up (≥1 years) mJOA score
Who cannot join
- prior head or neck surgery
- a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).
About this study
Official title: Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)
Utilization of T2* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)
Read the detailed description
Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal [ISI]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.
A new biomarker, T2* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.
- Conditions
- Cervical Spondylotic Myelopathy
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
T2* MRI
| Study group | Role | What they receive |
|---|---|---|
| mild CSM | preoperative modified Japanese Orthopedic Association (mJOA) score ≥15 Receives: Other: MRI | |
| moderate CSM | preoperative mJOA score 13~14 Receives: Other: MRI | |
| severe CSM | preoperative mJOA score ≤12 Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of neurologic function
Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time
Measured: at follow-up time (≥1 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study startJan 2010
- Primary completionJul 2020
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spondylotic MyelopathyStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955041
- Sponsor's protocol ID
- M2020317
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)
- ClinicalTrials.gov ID
- NCT04955041
- Acronym / sponsor ID
- M2020317
- Conditions
- Cervical Spondylotic Myelopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 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.
Utilization of T2* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)
Detailed description
Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal [ISI]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.
A new biomarker, T2* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild CSM | – | Other: MRIpreoperative modified Japanese Orthopedic Association (mJOA) score ≥15 |
| moderate CSM | – | Other: MRIpreoperative mJOA score 13~14 |
| severe CSM | – | Other: MRIpreoperative mJOA score ≤12 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients came from Peking University Third Hospital
Key inclusion criteria (4 listed)
- diagnosed with CSM and operated on by one senior orthopedist
- available preoperative MRI results
- high-quality image data with no motion artifacts
- available preoperative and long-term follow-up (≥1 years) mJOA score
Key exclusion criteria (2 listed)
- prior head or neck surgery
- a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIT2* MRI | Other | mild CSM, moderate CSM, severe CSM |
Primary outcome
Improvement of neurologic function
Time frame: at follow-up time (≥1 years)
Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No. No.
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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 principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylotic Myelopathy, run by Peking University Third Hospital.
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 4 inclusion and 2 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of neurologic function (time frame: at follow-up time (≥1 years)). 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 8 Jul 2021.