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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 010

Other trials in China

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.

  1. 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

  2. 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.

  1. First posted12 Jul 2021
  2. Study start1 Mar 2018
  3. Primary completion1 Jul 2018
  4. Study completion1 Jun 2019

Resources

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)
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

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.

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