MRINCT05343104
Osteoarthrosis on 7.0T Magnetic Resonance Imaging
An observational study of MRI and Osteoarthrosis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- MRI, Osteoarthrosis
- What is being tested?
- Magnetic resonance imaging
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 May 2025
- 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: patients with clinical diagnosis of patellar chondromalacia were continuously included.
Who may be able to join
- Age≥18 and ≤80
- Having no contraindications against MRI
- Clinically stable
Who cannot join
- Age#18 or #80
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Jiayu Huang, M.S., +86 17782407581, huang_jy_cocacola@163.com
About this study
This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.
Read the detailed description
7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.
- Conditions
- MRI, Osteoarthrosis
- Being tested
- Magnetic resonance imaging
- Keywords
- MRI, Osteoarthrosis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Patients recruited will receive Magnetic resonance imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
The thickness of the cartilage of patellar on 7T MRI scan
Thickness of different part of the cartilage of patellar measured based on axial PD images
Measured: baseline
The T2 mapping value of the patellar cartilage on 7T MRI scan
T2 relaxation times of the patellar cartilage measured based on T2 mapping
Measured: baseline
The abnormal signal in the infrapatellar fat pad
The exist of abnormal signal in the infrapatellar fat pad detected based on sagittal PD images
Measured: baseline
Secondary outcomes (2)
Signal change of the patellar chondral before and after rehabilitation
The correlation between abnormal change of the patellar chondral and reaction 1 month after rehabilitation
Measured: 1 month after rehabilitation
Signal change of the infrapatellar fat pad before and after rehabilitation
The correlation between abnormal signal in the infrapatellar fat pad and reaction 1 month after rehabilitation
Measured: 1 month after rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Apr 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343104
- Sponsor's protocol ID
- Osteoarthrosis-ChinaPLAGH
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarthrosis on 7.0T Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05343104
- Acronym / sponsor ID
- Osteoarthrosis-ChinaPLAGH
- Conditions
- MRI, Osteoarthrosis
- Keywords
- MRI, Osteoarthrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 25 Apr 2022 (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.
This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.
Detailed description
7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with clinical diagnosis of patellar chondromalacia were continuously included.
Key inclusion criteria (3 listed)
- Age≥18 and ≤80
- Having no contraindications against MRI
- Clinically stable
Key exclusion criteria (3 listed)
- Age#18 or #80
- Pregnancy and other contraindication to MRI scan
- Informed consent not obtained
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 |
|---|---|---|
| Magnetic resonance imagingPatients recruited will receive Magnetic resonance imaging. | Diagnostic test | – |
Primary outcome
The thickness of the cartilage of patellar on 7T MRI scan
Time frame: baseline
Thickness of different part of the cartilage of patellar measured based on axial PD images
The T2 mapping value of the patellar cartilage on 7T MRI scan
Time frame: baseline
T2 relaxation times of the patellar cartilage measured based on T2 mapping
The abnormal signal in the infrapatellar fat pad
Time frame: baseline
The exist of abnormal signal in the infrapatellar fat pad detected based on sagittal PD images
2 secondary outcomes
Signal change of the patellar chondral before and after rehabilitation
Time frame: 1 month after rehabilitation
Signal change of the infrapatellar fat pad before and after rehabilitation
Time frame: 1 month after rehabilitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
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 MRI and Osteoarthrosis, run by Chinese PLA General 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 3 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 25 Apr 2022. 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 Jiayu Huang, M.S. (+86 17782407581, huang_jy_cocacola@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The thickness of the cartilage of patellar on 7T MRI scan (time frame: baseline). The study lists 3 primary outcomes in all. 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 25 Apr 2022.