MRINCT04957043
Application of 3D-Matrix in Knee Joint Sports Injury
An observational study of MRI, run by Peking University Third Hospital at 1 site in China.
Trial summary
3 d scan sequence can realize continuous thin layer scanning, the thinnest layer thickness of 0.5 mm, to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can according to need to multiplanar reconstruction based on the original image, the image of the watch… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MRI
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 1 Jun 2019
- 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
- Adult, Older adult
Study population: About 150 inpatients planned to undergo MRI examination of knee joint
Who may be able to join
- Have a clear history of knee injury, clinically suspected knee injury, need MRI examination;
- Arthroscopy or treatment is planned.
Who cannot join
- Patients with the following diseases: rheumatoid arthritis, septic arthritis, tumor, anterior cruciate ligament mucinous degeneration, and articular fibrosis;
- Previous history of knee surgery;
- MRI contraindication: patients with metal in body (pacemaker, prosthetic eye, metal implant), pregnancy or claustrophobia;
- Arthroscopy was not performed after MRI examination for various reasons;
- The time interval between MRI examination and arthroscopy was more than 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of 3D Fast Spin-echo Sequence (3D-Matrix) Optimized by Compressed Sensing Technology in Knee Joint Sports Injury
3 d scan sequence can realize continuous thin layer scanning, the thinnest layer thickness of 0.5 mm, to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can according to need to multiplanar reconstruction based on the original image, the image of the watch is no longer limited to a fixed plane, and can avoid repeated scanning, reducing overall inspection time. Initially, 3D MRI uses gradient echo sequences (3D-GRE). Although the scan time of 3D-GRE is acceptable and has a high spatial resolution, the contrast between tissues is poor. In recent years, is voxel 3D fast spin-echo sequence (3D-FSE) has become an alternative 3D scanning sequence. Compared with the 3D-GRE sequence, 3D-FSE has better-intertissued contrast. However, there are still some problems in the application of 3D sequence in clinical practice. On the one hand, although 3D sequence reduces the overall scanning time, it increases the single scanning time, so it is easy to produce motion artifacts. On the other hand, although many studies have demonstrated the diagnostic efficacy of 3D sequences in the diagnosis of common intraarticular structural injuries, especially in the diagnosis of knee cartilage injuries, the diagnostic value of 3D sequences is comparable to that of conventional 2D-FSE sequences, but the evidence on whether 3D sequences can replace 2D sequences is still insufficient.
Recently, a new fast signal acquisition technology -- Compressed Sensing (Compressed Sensing) technology has been gradually applied to many kinds of MRI sequences, and its application in 3D sequences can greatly shorten the single scan time. In this study, Modulated Flip Angle Technique in Refocused Imaging with Extended Echo was applied by United Imaging Co., Ltd. (Compressed Sensing) Train, 3D-Matrix), which is a fast self-selected echo sequence based on variable turn Angle technology, and its single scan time can be shortened to 5 minutes. 3 d sequence to more systematic evaluation on sports injury of knee joint application value, the investigators will study from within the bony structure of knee joint injury, joint structure damage and injury of the surrounding support structure aspects to discuss the diagnosis effect, and with arthroscopy for the gold standard to evaluate the accuracy of the 3 d structure within the sequence in the diagnosis of knee joint injury.
Read the detailed description
Magnetic resonance imaging (MRI) is the most important non-invasive examination method for the diagnosis of knee joint sports injury. 2D-FSE sequence is usually used for axial, sagittal and coronal scanning in MR examination of the knee joint. The sequence has good tissue contrast and spatial resolution. However, there are still some problems with 2D-FSE sequences. For example, the scanning layer thickness is usually up to 3-5mm, and there is a certain layer spacing, resulting in partial volume effect. In addition, in order to obtain images with different azimuths, the same sequence needs to be scanned for many times, which increases the overall inspection time.
3 d scan sequence can realize continuous thin layer scanning, the most thin layer thickness of 0.5 mm , so as to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can be on the basis of the original image according to need multiplanar reconstruction, make the observation of the image is no longer limited to the fixed plane, and can avoid repeated scanning, reducing overall inspection time. Initially, 3D MRI uses gradient echo sequences (3D-GRE). Although the scan time of 3D-GRE is acceptable and has high spatial resolution, the contrast between tissues is poor. In recent years, the isosvoxel 3D fast spin echo sequence (3D-FSE) has become an alternative 3D scanning sequence. Compared with 3D-GRE sequence, 3D-FSE has better intertissue contrast . However, there are still some problems in the application of 3D sequences in clinical practice. On the one hand, although 3D sequences reduce the overall scanning time, the single scanning time increases. At present, the scanning time in most studies is generally 6-10 minutes , so motion artifacts are easily generated. On the other hand, although many studies have proved the diagnostic efficacy of 3D sequence in the diagnosis of common intraarticular structural injuries , especially the diagnostic value of 3D sequence in the diagnosis of knee cartilage injuries is equivalent to that of conventional 2D-FSE sequence, there is insufficient evidence on whether 3D sequence can replace 2D sequence .
Recently, a new fast signal acquisition technology -- Compressed Sensing (Compressed Sensing) technology has been gradually applied to a variety of MRI sequences , and its application in 3D sequences can greatly shorten the single scan time. In this study, Modulated Flip Angle Technique in Refocused Imaging with Extended Echo was applied by United Imaging Co., Ltd. (Compressed Sensing) Train, 3D-Matrix), which is a fast self-selected echo sequence based on variable turn Angle technology, and its single scan time can be shortened to 5 minutes. 3 d sequence in order to more systematic evaluation on sports injury of knee joint application value, the investigators will study from within the bony structure of knee joint injury, joint structure damage and injury of the surrounding support structure aspects to discuss the diagnosis effect, and with arthroscopy for gold standard to evaluate the accuracy of the 3 d structure within the sequence in the diagnosis of knee joint injury.
- Conditions
- MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the image quality of knee joint imaging with 3D-Matrix sequence
Evaluate the image quality of knee joint imaging with 3D-Matrix sequence
Measured: 2018-2019
Evaluate the image accuracy of knee joint imaging with 3D-Matrix sequence
Using arthroscopy as the gold standard, the accuracy of 3D-Matrix and conventional 2D-FSE sequences in the diagnosis of anterior cruciate ligament (ACL), meniscus and articular cartilage injuries was compared.
Measured: 2018-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Mar 2018
- Primary completion1 Jul 2018
- Study completion1 Jun 2019
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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
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
- NCT04957043
- Sponsor's protocol ID
- M2018017
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 12 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 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Fast Spin-echo Sequence (3D-Matrix) Optimized by Compressed Sensing Technology in Knee Joint Sports Injury
- ClinicalTrials.gov ID
- NCT04957043
- Acronym / sponsor ID
- M2018017
- Conditions
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 12 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.
3 d scan sequence can realize continuous thin layer scanning, the thinnest layer thickness of 0.5 mm, to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can according to need to multiplanar reconstruction based on the original image, the image of the watch is no longer limited to a fixed plane, and can avoid repeated scanning, reducing overall inspection time. Initially, 3D MRI uses gradient echo sequences (3D-GRE). Although the scan time of 3D-GRE is acceptable and has a high spatial resolution, the contrast between tissues is poor. In recent years, is voxel 3D fast spin-echo sequence (3D-FSE) has become an alternative 3D scanning sequence. Compared with the 3D-GRE sequence, 3D-FSE has better-intertissued contrast. However, there are still some problems in the application of 3D sequence in clinical practice. On the one hand, although 3D sequence reduces the overall scanning time, it increases the single scanning time, so it is easy to produce motion artifacts. On the other hand, although many studies have demonstrated the diagnostic efficacy of 3D sequences in the diagnosis of common intraarticular structural injuries, especially in the diagnosis of knee cartilage injuries, the diagnostic value of 3D sequences is comparable to that of conventional 2D-FSE sequences, but the evidence on whether 3D sequences can replace 2D sequences is still insufficient.
Recently, a new fast signal acquisition technology -- Compressed Sensing (Compressed Sensing) technology has been gradually applied to many kinds of MRI sequences, and its application in 3D sequences can greatly shorten the single scan time. In this study, Modulated Flip Angle Technique in Refocused Imaging with Extended Echo was applied by United Imaging Co., Ltd. (Compressed Sensing) Train, 3D-Matrix), which is a fast self-selected echo sequence based on variable turn Angle technology, and its single scan time can be shortened to 5 minutes. 3 d sequence to more systematic evaluation on sports injury of knee joint application value, the investigators will study from within the bony structure of knee joint injury, joint structure damage and injury of the surrounding support structure aspects to discuss the diagnosis effect, and with arthroscopy for the gold standard to evaluate the accuracy of the 3 d structure within the sequence in the diagnosis of knee joint injury.
Detailed description
Magnetic resonance imaging (MRI) is the most important non-invasive examination method for the diagnosis of knee joint sports injury. 2D-FSE sequence is usually used for axial, sagittal and coronal scanning in MR examination of the knee joint. The sequence has good tissue contrast and spatial resolution. However, there are still some problems with 2D-FSE sequences. For example, the scanning layer thickness is usually up to 3-5mm, and there is a certain layer spacing, resulting in partial volume effect. In addition, in order to obtain images with different azimuths, the same sequence needs to be scanned for many times, which increases the overall inspection time.
3 d scan sequence can realize continuous thin layer scanning, the most thin layer thickness of 0.5 mm , so as to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can be on the basis of the original image according to need multiplanar reconstruction, make the observation of the image is no longer limited to the fixed plane, and can avoid repeated scanning, reducing overall inspection time. Initially, 3D MRI uses gradient echo sequences (3D-GRE). Although the scan time of 3D-GRE is acceptable and has high spatial resolution, the contrast between tissues is poor. In recent years, the isosvoxel 3D fast spin echo sequence (3D-FSE) has become an alternative 3D scanning sequence. Compared with 3D-GRE sequence, 3D-FSE has better intertissue contrast . However, there are still some problems in the application of 3D sequences in clinical practice. On the one hand, although 3D sequences reduce the overall scanning time, the single scanning time increases. At present, the scanning time in most studies is generally 6-10 minutes , so motion artifacts are easily generated. On the other hand, although many studies have proved the diagnostic efficacy of 3D sequence in the diagnosis of common intraarticular structural injuries , especially the diagnostic value of 3D sequence in the diagnosis of knee cartilage injuries is equivalent to that of conventional 2D-FSE sequence, there is insufficient evidence on whether 3D sequence can replace 2D sequence .
Recently, a new fast signal acquisition technology -- Compressed Sensing (Compressed Sensing) technology has been gradually applied to a variety of MRI sequences , and its application in 3D sequences can greatly shorten the single scan time. In this study, Modulated Flip Angle Technique in Refocused Imaging with Extended Echo was applied by United Imaging Co., Ltd. (Compressed Sensing) Train, 3D-Matrix), which is a fast self-selected echo sequence based on variable turn Angle technology, and its single scan time can be shortened to 5 minutes. 3 d sequence in order to more systematic evaluation on sports injury of knee joint application value, the investigators will study from within the bony structure of knee joint injury, joint structure damage and injury of the surrounding support structure aspects to discuss the diagnosis effect, and with arthroscopy for gold standard to evaluate the accuracy of the 3 d structure within the sequence in the diagnosis of knee joint injury.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- About 150 inpatients planned to undergo MRI examination of knee joint
Key inclusion criteria (2 listed)
- Have a clear history of knee injury, clinically suspected knee injury, need MRI examination;
- Arthroscopy or treatment is planned.
Key exclusion criteria (5 listed)
- Patients with the following diseases: rheumatoid arthritis, septic arthritis, tumor, anterior cruciate ligament mucinous degeneration, and articular fibrosis;
- Previous history of knee surgery;
- MRI contraindication: patients with metal in body (pacemaker, prosthetic eye, metal implant), pregnancy or claustrophobia;
- Arthroscopy was not performed after MRI examination for various reasons;
- The time interval between MRI examination and arthroscopy was more than 2 months.
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
Evaluate the image quality of knee joint imaging with 3D-Matrix sequence
Time frame: 2018-2019
Evaluate the image quality of knee joint imaging with 3D-Matrix sequence
Evaluate the image accuracy of knee joint imaging with 3D-Matrix sequence
Time frame: 2018-2019
Using arthroscopy as the gold standard, the accuracy of 3D-Matrix and conventional 2D-FSE sequences in the diagnosis of anterior cruciate ligament (ACL), meniscus and articular cartilage injuries was compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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 MRI, 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 5 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: finished, as of the sponsor's last update on 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the image quality of knee joint imaging with 3D-Matrix sequence (time frame: 2018-2019). The study lists 2 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 12 Jul 2021.