Clinical trial NCT02809625: Application of DCE-MRI in the Diagnosis of Brucellar Spondylitis
Official title: Application of Dynamic Contrast Enhanced MRI in Clinical and Early Diagnosis of Brucellar Spondylitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brucella Spondylitis
Keywords: Dynamic contrast -enhanced MRI
brucella spondylitis
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2016-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 100 patients with Brucellosis including patients with brucella spondylitis obviously and patients with obvious waist pain but the conventional MRI showed no obvious abnormalities were selected.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Inner Mongolia
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
Study officials:
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Peng fei Qiao, MD
role: STUDY_DIRECTOR
References: