Brucella SpondylitisNCT02809625
Application of DCE-MRI in the Diagnosis of Brucellar Spondylitis
An observational study of Brucella Spondylitis, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 35 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Brucella Spondylitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- The epidemiological exposure history of different extents, accompanied with symptoms including
- low fever
- night sweats
- intermittent lower back pain
- movement limitation
Who cannot join
- With other disease like tuberculous spondylitis,vertebral metastases,etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Inner Mongolia
Peng fei Qiao, MD, +86-15904718239, qpfff@126.com
Yang Gao, PhD, +86-15024931010, 24853170@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Brucella Spondylitis
- Keywords
- Dynamic contrast -enhanced MRI, brucella spondylitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brucella SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor
- Investigators
- Peng fei Qiao, MD, Study director, The Affiliated Hospital of Inner Mongolia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809625
- Sponsor's protocol ID
- AHInnerMongolia
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2016
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Dynamic Contrast Enhanced MRI in Clinical and Early Diagnosis of Brucellar Spondylitis
- ClinicalTrials.gov ID
- NCT02809625
- Acronym / sponsor ID
- AHInnerMongolia
- Conditions
- Brucella Spondylitis
- Keywords
- Dynamic contrast -enhanced MRI, brucella spondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Mar 2016
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- The epidemiological exposure history of different extents, accompanied with symptoms including
- low fever
- night sweats
- intermittent lower back pain
- movement limitation
Key exclusion criteria (1 listed)
- With other disease like tuberculous spondylitis,vertebral metastases,etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng fei Qiao, MD study director
The Affiliated Hospital of Inner Mongolia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brucella Spondylitis, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng fei Qiao, MD (+86-15904718239, qpfff@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The useful value of dynamic contrast-enhanced MRI in clinical diagnosis and early diagnosis of brucella spondylitis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.