NCT06220500

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.

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 Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

January 11, 2024

Last Update Submit

January 22, 2024

Conditions

Keywords

RadiomicsMRI

Outcome Measures

Primary Outcomes (1)

  • The useful value of radiomics of MRI in BS clinical diagnosis.

    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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Outpatients/Inpatients
  • Age 18-70 years
  • Meet diagnostic criteria for brucellosis
  • Meet symptoms of brucellosis spondylitis
  • Voluntarily sign an informed consent form
  • Can cooperate with MRI examination

You may not qualify if:

  • Patients with serious diseases of other systems
  • History of malignant tumors of the vertebral body
  • History of tuberculosis
  • Contraindications to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, 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

January 11, 2024

First Posted

January 24, 2024

Study Start

January 1, 2023

Primary Completion

August 1, 2024

Study Completion

December 1, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations