New MRI Sequences in Spine and Joint

NCT ID: NCT04647279

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Degeneration of Spine and Osteoarticular

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal control group

Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

Dual-emission X-ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.

Osteopenia

Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

Dual-emission X-ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.

Osteoporosis

Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM

Dual-emission X-ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.

Interventions

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Dual-emission X-ray Absorptiometry

The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1.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.

Exclusion Criteria

* 1\. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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ShaoLin Li

Director of Radiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin Liu, Master

Role: CONTACT

0086 756 2528321

Shaolin Li, Director

Role: CONTACT

0086 756 2528321

Facility Contacts

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Jin Liu, Master

Role: primary

0086 756 2528321

Shaolin Li, Doctor

Role: backup

0086 756 2528321

References

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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.

Reference Type BACKGROUND
PMID: 9646768 (View on PubMed)

Bae 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.

Reference Type BACKGROUND
PMID: 23192776 (View on PubMed)

Freburger 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.

Reference Type BACKGROUND
PMID: 19204216 (View on PubMed)

Lotz 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.

Reference Type BACKGROUND
PMID: 24436866 (View on PubMed)

Gatehouse 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.

Reference Type BACKGROUND
PMID: 12565203 (View on PubMed)

Bae 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.

Reference Type BACKGROUND
PMID: 20177096 (View on PubMed)

Bae 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.

Reference Type BACKGROUND
PMID: 22129641 (View on PubMed)

Pfirrmann 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.

Reference Type BACKGROUND
PMID: 11568697 (View on PubMed)

GBD 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.

Reference Type BACKGROUND
PMID: 27733282 (View on PubMed)

Hoy 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.

Reference Type BACKGROUND
PMID: 22231424 (View on PubMed)

Other Identifiers

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ZDWY.FSK.004

Identifier Type: -

Identifier Source: org_study_id

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