NCT02809625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

7.8 years

First QC Date

June 16, 2016

Last Update Submit

July 18, 2023

Conditions

Keywords

Dynamic contrast -enhanced MRIbrucella spondylitis

Outcome Measures

Primary Outcomes (1)

  • The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis

    2 years

Eligibility Criteria

Age35 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • The epidemiological exposure history of different extents, accompanied with symptoms including
  • low fever
  • night sweats
  • intermittent lower back pain
  • movement limitation

You may not qualify if:

  • With other disease like tuberculous spondylitis,vertebral metastases,etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Inner Mongolia Medical University

Inner Mongolia, China

RECRUITING

Study Officials

  • Peng fei Qiao, MD

    The Affiliated Hospital of Inner Mongolia Medical University

    STUDY DIRECTOR

Central Study Contacts

Peng fei Qiao, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations