Application of DCE-MRI in the Diagnosis of Brucellar Spondylitis

July 18, 2023 updated by: The Affiliated Hospital of Inner Mongolia Medical University

Application of Dynamic Contrast Enhanced MRI in Clinical and Early Diagnosis of Brucellar Spondylitis

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peng fei Qiao, MD
  • Phone Number: +86-15904718239
  • Email: qpfff@126.com

Study Contact Backup

Study Locations

  • China
      • Inner Mongolia, China
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Peng fei Qiao, MD
          • Phone Number: +86-15904718239
          • Email: qpfff@126.com
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Inner Mongolia Medical University

Collaborators

National Natural Science Foundation of China

Investigators

  • Study Director: Peng fei Qiao, MD, The Affiliated Hospital of Inner Mongolia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 18, 2016

First Posted (Estimated)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHInnerMongolia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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