New MRI Sequences in Spine and Joint
NMSSJ
Clinical Study of New MRI Sequences in Spine and Joint
1 other identifier
observational
300
1 country
1
Brief Summary
Low back pain and osteoarticular degeneration or injury is the leading worldwide cause of years lost to disability, accounting for 17 % of all patients with disabilities and its burden is growing alongside the increasing and aging population. The anatomical regions of the intervertebral disc include the central nucleus pulposus, the peripheral fibrocartilaginous annulus fibrosus, and the superior and inferior cartilaginous endplates (CEP). The CEP is a thin layer of hyaline cartilage located between the avascular intervertebral disc and the bony vertebral endplate. The endplate cartilage consists of chondrocytes interspersed throughout an extracellular matrix of proteoglycans, collagen (types I and II), and water. It plays an important role in the function and homeostasis. The CEP has been considered the pathway between the largely avascular disk tissues and the blood supply of the vertebral body and thus provides nutrition for disk cells. Many musculoskeletal tissues, including the CEP, cartilage-bone interface of articular joints, entheses, tendons, and ligaments, have components with very short T2 values (much less than 1 msec), which are orders of magnitude shorter than that of the nucleus of the disk (\~100 msec). In a conventional pulse sequence, such as proton density-weighted spin-echo (SE) or fast SE, with standard clinical section profile, the minimum echo time (TE) is typically 10 msec, which is much longer than that needed to capture the short-lived signal from these tissues. Recently, ultrashort echo sequence UTE technology has been introduced, and the TE time can be as low as 0.008ms. This range of TE is sufficient to capture signals from the cartilage endplate before it decays. With using new MRI technology, such as IR-UTE, UTE-MT, UTE-T2\*mapping, Maigc, DTI, and IVIM, which can quantitative tissues that have previously been "invisible" at conventional MR imaging, and provide imaging basis for early diagnosis of injury at molecular level. The purpose of this study was to investigate the clinical application value of different MRI sequences in spine and joint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 6, 2021
April 1, 2021
2.2 years
November 27, 2020
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New MRI sequences in the diagnosis of spine and joint
Quantitative MRI imaging(such as IR-UTE, UTE-MT, UTE-T2\*mapping, Maigc, Ideal IQ, DTI, and IVIM) used to quantitative diagnosis of disk degeneration, osteoporosis, osteoarticular degeneration etc.
2 years
Study Arms (3)
Normal control group
Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM
Osteopenia
Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM
Osteoporosis
Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM
Interventions
The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.
Eligibility Criteria
All suspected patients with osteoporosis and low back pain meet the inclusion criteria will include in this study. And patients who meet the criteria of the normal control group will include in this study.
You may qualify if:
- The patient had history and clinical symptoms of low back pain and joint sports injury 2.The patient had a history of osteoporosis; 3.There was no contraindication of MRI; 4.The patient who has clear lumbar intervertebral disc degeneration or herniation or osteoporosis or joint sports injury found by routine CT or MRI examination, and the clinical symptoms were consistent with the image.
You may not qualify if:
- \. Patients with previous history of lumbar or joint surgery; 2. Patients with congenital bone deformity; 3. Patients with history of lumbar tumor and infection; 4. Cognitive function is limited or mental illness can not cooperate with imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000, China
Related Publications (10)
Kawakami M, Tamaki T, Hayashi N, Hashizume H, Nishi H. Possible mechanism of painful radiculopathy in lumbar disc herniation. Clin Orthop Relat Res. 1998 Jun;(351):241-51.
PMID: 9646768BACKGROUNDBae WC, Statum S, Zhang Z, Yamaguchi T, Wolfson T, Gamst AC, Du J, Bydder GM, Masuda K, Chung CB. Morphology of the cartilaginous endplates in human intervertebral disks with ultrashort echo time MR imaging. Radiology. 2013 Feb;266(2):564-74. doi: 10.1148/radiol.12121181. Epub 2012 Nov 28.
PMID: 23192776BACKGROUNDFreburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
PMID: 19204216BACKGROUNDLotz JC, Fields AJ, Liebenberg EC. The role of the vertebral end plate in low back pain. Global Spine J. 2013 Jun;3(3):153-64. doi: 10.1055/s-0033-1347298. Epub 2013 May 23.
PMID: 24436866BACKGROUNDGatehouse PD, Bydder GM. Magnetic resonance imaging of short T2 components in tissue. Clin Radiol. 2003 Jan;58(1):1-19. doi: 10.1053/crad.2003.1157.
PMID: 12565203BACKGROUNDBae WC, Dwek JR, Znamirowski R, Statum SM, Hermida JC, D'Lima DD, Sah RL, Du J, Chung CB. Ultrashort echo time MR imaging of osteochondral junction of the knee at 3 T: identification of anatomic structures contributing to signal intensity. Radiology. 2010 Mar;254(3):837-45. doi: 10.1148/radiol.09081743.
PMID: 20177096BACKGROUNDBae WC, Du J, Bydder GM, Chung CB. Conventional and ultrashort time-to-echo magnetic resonance imaging of articular cartilage, meniscus, and intervertebral disk. Top Magn Reson Imaging. 2010 Oct;21(5):275-89. doi: 10.1097/RMR.0b013e31823ccebc.
PMID: 22129641BACKGROUNDPfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976). 2001 Sep 1;26(17):1873-8. doi: 10.1097/00007632-200109010-00011.
PMID: 11568697BACKGROUNDGBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PMID: 27733282BACKGROUNDHoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PMID: 22231424BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Radiology Department
Study Record Dates
First Submitted
November 27, 2020
First Posted
November 30, 2020
Study Start
June 1, 2020
Primary Completion
July 31, 2022
Study Completion
December 31, 2022
Last Updated
April 6, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share