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New MRI Sequences in Spine and Joint (NMSSJ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04647279
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment
Degeneration of Spine and Osteoarticular Diagnostic Test: Dual-emission X-ray Absorptiometry

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Clinical Study of New MRI Sequences in Spine and Joint
Estimated Study Start Date : November 27, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Group/Cohort Intervention/treatment
Normal control group
Diagnostic Test: Quantitative MRI imaging IR-UTE, UTE-MT, Maigc, Ideal IQ, DTI, and IVIM
Diagnostic Test: Dual-emission X-ray Absorptiometry
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
Diagnostic Test: Dual-emission X-ray Absorptiometry
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
Diagnostic Test: Dual-emission X-ray Absorptiometry
The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.




Primary Outcome Measures :
  1. New MRI sequences in the diagnosis of spine and joint [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647279


Contacts
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Contact: Jin Liu, Master 0086 756 2528321 602046738@qq.com
Contact: Shaolin Li, Director 0086 756 2528321 lishaolin1963@126.com

Locations
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China, Guangdong
The Fifth Affiliated Hospital of Sun Yat-sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Jin Liu, Master    0086 756 2528321    602046738@qq.com   
Contact: Shaolin Li, Doctor    0086 756 2528321    lishaolin1963@126.com   
Sponsors and Collaborators
Fifth Affiliated Hospital, Sun Yat-Sen University
Publications:

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Responsible Party: ShaoLin Li, Director of Radiology Department, Fifth Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04647279    
Other Study ID Numbers: ZDWY.FSK.004
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ShaoLin Li, Fifth Affiliated Hospital, Sun Yat-Sen University:
Magnetic resonance imaging
Low back pain
Disk degeneration
Ultrashort echo time
Osteoarticular degeneration