Brucella SpondylitisNCT06220500
Radiomics Analysis Based on MRI to Detect Brucella Spondylitis
An observational study of Brucella Spondylitis, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brucella Spondylitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with serious diseases of other systems
- History of malignant tumors of the vertebral body
- History of tuberculosis
- Contraindications to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Peng fei Qiao, 15904718239, 24853170@qq.com
Peng fei Qiao
About this study
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.
Read the 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.
- Conditions
- Brucella Spondylitis
- Keywords
- Radiomics, MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2023
- Primary completionAug 2024 (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
- 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
- NCT06220500
- Sponsor's protocol ID
- AHInnerMongolia-BS
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics Analysis Based on MRI to Detect Brucella Spondylitis
- ClinicalTrials.gov ID
- NCT06220500
- Acronym / sponsor ID
- AHInnerMongolia-BS
- Conditions
- Brucella Spondylitis
- Keywords
- Radiomics, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Outpatients/Inpatients
- Age 18-70 years
- Meet diagnostic criteria for brucellosis
- Meet symptoms of brucellosis spondylitis
- Voluntarily sign an informed consent form
Key exclusion criteria (4 listed)
- Patients with serious diseases of other systems
- History of malignant tumors of the vertebral body
- History of tuberculosis
- Contraindications to magnetic resonance imaging
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 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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 6 inclusion and 4 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 24 Jan 2024. 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 (15904718239, 24853170@qq.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 radiomics of MRI in BS clinical diagnosis. (time frame: December 2024). 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 24 Jan 2024.