Clinical trial NCT06220500: Radiomics Analysis Based on MRI to Detect Brucella Spondylitis
Official title: Radiomics Analysis Based on MRI to Detect Brucella Spondylitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brucella Spondylitis
Keywords: Radiomics
MRI
Lead sponsor: The Affiliated Hospital of Inner Mongolia Medical University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 and the conventional MRI showed abnormalities were selected.

Brief summary: Brucella spondylitis, an infectious spinal disease caused by the invasion of Brucella bacteria into the body. Its diagnosis relies mainly on laboratory and imaging tests. Due to the limited diagnostic ability of X-ray and CT for Brucella spondylitis, MRI has become the main diagnostic tool. In recent years, functional magnetic resonance technology has demonstrated great advantages in the diagnosis and therapeutic evaluation of brucellosis spondylitis, which can provide pathophysiologic information about the disease and is also a noninvasive and noninvasive diagnostic tool with a broader application prospect. Radiomics, an emerging approach, has also shown better diagnostic efficacy for this disease.

Detailed description: The investigators will incorporate 100 confirmed cases of Brucella spondylitis (BS) patients diagnosed at Affiliated Hospital of Inner Mongolia Medical University. The patients receive routine scan with a Siemens Skyra 3.0T MRI scanner and the investigators collect clinical data and blood test results from the patients.The investigators segment the affected vertebral bodies by ITK-SNAP software on STIR images to create three-dimensional regions of interest. Then use Onekey software to extract radiomics features from the affected vertebral bodies. Employed t-tests and Lasso regression to select radiomics features. Then separately use radiomics features and combining it with clinical information to build random vector machine(SVM) and random forest(RF) models . All the models are constructed in the training set and their performance are evaluated on the validation set.

Eligibility criteria: Inclusion Criteria:

1. Outpatients/Inpatients
2. Age 18-70 years
3. Meet diagnostic criteria for brucellosis
4. Meet symptoms of brucellosis spondylitis
5. Voluntarily sign an informed consent form
6. Can cooperate with MRI examination

Exclusion Criteria:

1. Patients with serious diseases of other systems
2. History of malignant tumors of the vertebral body
3. History of tuberculosis
4. Contraindications to magnetic resonance imaging

Primary outcomes:
measure: The useful value of radiomics of MRI in BS clinical diagnosis.
timeFrame: December 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
Study officials:
affiliation: The Affiliated Hospital of Inner Mongolia Medical University
name: Peng fei Qiao, MD
role: STUDY_DIRECTOR
References: