Radiomics Analysis Based on MRI to Detect Brucella Spondylitis

January 22, 2024 updated by: The Affiliated Hospital of Inner Mongolia Medical University
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.

Study Overview

Status

Recruiting

Conditions

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.

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

Study Locations

  • China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
        • Principal Investigator:
          • Peng fei Qiao

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The useful value of radiomics of MRI in BS clinical diagnosis.
Time Frame: December 2024
The investigators will validate the results. The validation and external test cohorts will be used to evaluate the performance of the prediction models. The micro-avg and macro-avg precision, true positive (TP), true negative (TN), false positive (FP), false negative (FN), accuracy, sensitivity, specificity, and F1 score of different models will be calculated. Receiver operating characteristic (ROC) curves is going to be used to assess the sensitivity and specificity of the models, and the area under the ROC curve (AUC) was used to describe the discriminative power of the models. The investigators think radiomics of MRI can provide a reliable basis for early damage in brucellosis spondylitis and provides evidence for early clinical intervention.
December 2024

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

Investigators

  • Study Director: Peng fei Qiao, MD, 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 (Actual)

January 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Estimated)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHInnerMongolia-BS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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