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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02809625
Other study ID # AHInnerMongolia
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2016
Est. completion date December 2024

Study information

Verified date July 2023
Source The Affiliated Hospital of Inner Mongolia Medical University
Contact Peng fei Qiao, MD
Phone +86-15904718239
Email qpfff@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Brucellosis, also known as Mediterranean fever, undulant fever, or Malta fever is a zoonotic disease caused by Brucella infection.With the rapid development of animal husbandry and aquaculture and increasing consumption of dairy products in urban residents, the incidence of this disease in Inner Mongolia and even in the mainland area of China is significantly increased. The disease can damage multiple systems including nervous system, circulatory system, reproductive system and bone joints, etc. The sooner the diagnosis of brucellar spondylitis is diagnosed and treated, the better will be the prognosis of the patients which can prevent the development of severe complications and diminish the need for surgical therapy. Thus the early diagnosis of brucellar spondylitis was of great significance.We quantitatively analyzed the brucellar spondylitis with DCE-MRI to explore the application of DCE-MRI in the early diagnosis of brucellar spondylitis.


Description:

About 100 patients with Brucellosis were conducted with conventional MRI and dynamic contrast-enhanced MRI(DCE-MRI) scan. The variations of the value of ktrans(endothelial transfer constant),kep(reflux rate),Ve(fractional extracellular fluid space volume) and Vp(fractional plasma volume) between the vertebral lesions,Early lesions of vertebral body and normal tissues were measured and compared. And under the receiver operating characteristic(ROC) curve analysis,we will calculate the sensitivity and specificity of Ktrans,Kep,Ve and Vp in the diagnosis and early diagnosis of brucella spondylitis .The values of Ktrans,Kep,Ve and Vp will be studied between the vertebral lesions and normal tissues, the early lesions of vertebral body and normal tissues.The sensitivity and specificity of both parameters (Ktrans、Kep、Ve、Vp)will be done.The valve of DCE-MRI in the diagnosis and early diagnosis of the brucella spondylitis will be analysed.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 62 Years
Eligibility Inclusion Criteria: The epidemiological exposure history of different extents, accompanied with symptoms including - low fever - night sweats - intermittent lower back pain - movement limitation Exclusion Criteria: - With other disease like tuberculous spondylitis,vertebral metastases,etc

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The Affiliated Hospital of Inner Mongolia Medical University Inner Mongolia

Sponsors (2)

Lead Sponsor Collaborator
The Affiliated Hospital of Inner Mongolia Medical University National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis 2 years
See also
  Status Clinical Trial Phase
Completed NCT06432530 - Can Hematological Inflammatory Indexes be Used to Differentiate Type 1 Modic Changes From Brucella Spondylodiscitis
Recruiting NCT06220500 - Radiomics Analysis Based on MRI to Detect Brucella Spondylitis