Low Back PainNCT06248827
Creation of a Clinical Database of Lumbar Spine MRI
An observational study of Low Back Pain, run by Caerus Medical.
Trial summary
The creation of a clinical database including patients who suffer from low back pain and underwent a lumbar spine MRI Exam. This database will allow us to : Collect patients symptoms, medical history, and MRI exams Launch the annotation of the MRI exams by expert radiologists Link and relate information between the… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Data Collection
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Apr 2025
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (over 18 years of age), men and women, suffering of low back pain who underwent a lumbar spine MRI exam
Who may be able to join
- Adult patient aged ≥ 18, no age limit;
- Suffering of low back pain ;
- Patient exam performed at the Centre Hospiralier Universitaire de Montreal (CHUM), Canada
Who cannot join
- Patients with orthopedic material
- Patients with traumatic cases (ex : accidents)
Trial locations and contacts
No sites are listed yet.
About this study
The creation of a clinical database including patients who suffer from low back pain and underwent a lumbar spine MRI Exam.
This database will allow us to :
- Collect patients symptoms, medical history, and MRI exams
- Launch the annotation of the MRI exams by expert radiologists
- Link and relate information between the exams and the diagnostic done by the experts
- Train and develop a diagnostic platform for th spinal pathologies based on artificial intelligence.
Read the detailed description
Low back pain is classically characterized by pain in the lower back, which may be accompanied by varying degrees of restricted mobility and pain radiating down to the feet. The management of low back pain is a global public health issue, since it represents one of the major causes of disability worldwide.
Degenerative disc disease (DDD) is the most common underlying pathology. These include herniated discs, pinched discs and degenerative spondylolisthesis (slippage of one vertebra in relation to its neighbor). Worldwide, 266 million patients suffer from DDD every year. The socio-economic impact of these pathologies is considerable.
DDD results from a variety of pathologies that may interact with each other. The diversity of these pathologies and the complexity of their interactions often lead to failure of a clear diagnosis, and consequently to inappropriate treatment.
In clinical practice, MRI is the reference test for the diagnosis of these pathologies, but inter-observer reliability remains moderate between 2 practitioners (sensitivity 56% and Cohen's κ ⊂ [0.41-0.6]) or even low (κ ⊂ [0.21-0.4]) between 2 practitioners of different specialties. So there is still a major gap to be bridged in order to make radiologists' diagnoses more reliable and standardized.
In this context, the creation of a clinical database including patient symtoms and exams is of hogh interest.Thsi database will allow us to :
- Annotate the MRI exams by experts radiologists in order to train and develop AI algorithms
- Create a tool to support radiologists in their diagnoses would therefore be a considerable step forward. Such a tool, combined with non-invasive data, would make it possible to establish a specific diagnosis early on,
The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of correlations between MRI findings, the patients symptoms and the origin of the low back pain.
- Conditions
- Low Back Pain
- Being tested
- Data Collection
- Keywords
- Low back pain, MRI
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Patient data : gender, age, height, weight, daily life (type of job) Diagnostic data : Description of first symptoms/medical history (pain), previous medical history, MRI exams
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Spine MRI exams | An information letter will be delivered by the investigator physician to the patients to inform them on the study, its implementation and their complete freedom to participate or not.
1. MRI Data from exams (DICOM format)
* Sagittal T1
* Sagittal T2
* Sagittal DIXON
* Sagittal STIR
* Sagittal FLAIR
* Axial T2
2. Clinical Data from questionnaires
* biometric data (height, weight),
* age
* gender,
* smoking status,
* comorbidities,
* basic clinical examination,
* medical history. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada.
Measured: 1 year
Secondary outcomes (1)
Data annotation and developpment of artificial intelligence algorithms
- Annotation of the lumbar spine MRI exams by experts radiologists according to a standardized annotation protocol for lumbar spine pathologies.
- Training of artificial intelligence algorithms based on the database created and annotation collected.
- Development of a diagnostic platform for spinal pathologies.
- Realization of clinical studies specific the annotations on the MRI exams and the patient prevalence.
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 posted8 Feb 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caerus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248827
- Sponsor's protocol ID
- CM-01
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Clinical Database of Lumbar Spine MRI
- ClinicalTrials.gov ID
- NCT06248827
- Acronym / sponsor ID
- CM-01
- Conditions
- Low Back Pain
- Keywords
- Low back pain, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Caerus MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 8 Feb 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.
The creation of a clinical database including patients who suffer from low back pain and underwent a lumbar spine MRI Exam.
This database will allow us to :
- Collect patients symptoms, medical history, and MRI exams
- Launch the annotation of the MRI exams by expert radiologists
- Link and relate information between the exams and the diagnostic done by the experts
- Train and develop a diagnostic platform for th spinal pathologies based on artificial intelligence.
Detailed description
Low back pain is classically characterized by pain in the lower back, which may be accompanied by varying degrees of restricted mobility and pain radiating down to the feet. The management of low back pain is a global public health issue, since it represents one of the major causes of disability worldwide.
Degenerative disc disease (DDD) is the most common underlying pathology. These include herniated discs, pinched discs and degenerative spondylolisthesis (slippage of one vertebra in relation to its neighbor). Worldwide, 266 million patients suffer from DDD every year. The socio-economic impact of these pathologies is considerable.
DDD results from a variety of pathologies that may interact with each other. The diversity of these pathologies and the complexity of their interactions often lead to failure of a clear diagnosis, and consequently to inappropriate treatment.
In clinical practice, MRI is the reference test for the diagnosis of these pathologies, but inter-observer reliability remains moderate between 2 practitioners (sensitivity 56% and Cohen's κ ⊂ [0.41-0.6]) or even low (κ ⊂ [0.21-0.4]) between 2 practitioners of different specialties. So there is still a major gap to be bridged in order to make radiologists' diagnoses more reliable and standardized.
In this context, the creation of a clinical database including patient symtoms and exams is of hogh interest.Thsi database will allow us to :
- Annotate the MRI exams by experts radiologists in order to train and develop AI algorithms
- Create a tool to support radiologists in their diagnoses would therefore be a considerable step forward. Such a tool, combined with non-invasive data, would make it possible to establish a specific diagnosis early on,
The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of correlations between MRI findings, the patients symptoms and the origin of the low back pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Spine MRI exams | – | Other: Data CollectionAn information letter will be delivered by the investigator physician to the patients to inform them on the study, its implementation and their complete freedom to participate or not. 1. MRI Data from exams (DICOM format) * Sagittal T1 * Sagittal T2 * Sagittal DIXON * Sagittal STIR * Sagittal FLAIR * Axial T2 2. Clinical Data from questionnaires * biometric data (height, weight), * age * gender, * smoking status, * comorbidities, * basic clinical examination, * medical history. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (over 18 years of age), men and women, suffering of low back pain who underwent a lumbar spine MRI exam
Key inclusion criteria (3 listed)
- Adult patient aged ≥ 18, no age limit;
- Suffering of low back pain ;
- Patient exam performed at the Centre Hospiralier Universitaire de Montreal (CHUM), Canada
Key exclusion criteria (2 listed)
- Patients with orthopedic material
- Patients with traumatic cases (ex : accidents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionPatient data : gender, age, height, weight, daily life (type of job) Diagnostic data : Description of first symptoms/medical history (pain), previous medical history, MRI exams | Other | Lumbar Spine MRI exams |
Primary outcome
Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada.
Time frame: 1 year
1 secondary outcome
Data annotation and developpment of artificial intelligence algorithms
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 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Caerus Medical.
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 3 inclusion and 2 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 David Vittecoq (0033650385980, dvittecoq@caerusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada. (time frame: 1 year). 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 Aug 2024.