Creation of a Clinical Database of Lumbar Spine MRI

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Data Collection

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 :

1. Annotate the MRI exams by experts radiologists in order to train and develop AI algorithms
2. 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: David Vittecoq; Phone Number: 0033650385980; Email: dvittecoq@caerusmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (over 18 years of age), men and women, suffering of low back pain who underwent a lumbar spine MRI exam

Description

Inclusion Criteria:

• Adult patient aged ≥ 18, no age limit;
• Suffering of low back pain ;
• Patient exam performed at the Centre Hospiralier Universitaire de Montreal (CHUM), Canada

Exclusion Criteria:

• Patients with orthopedic material
• Patients with traumatic cases (ex : accidents)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; MRI Data from exams (DICOM format)Sagittal T1Sagittal T2Sagittal DIXONSagittal STIRSagittal FLAIRAxial T2; Clinical Data from questionnairesbiometric data (height, weight),agegender,smoking status,comorbidities,basic clinical examination,medical history.

Other: Data Collection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish a database of patients who underwent a MRI exam of the lumbar spine at the Centre Hospitalier Universitaire de Montreal (CHUM) in Canada.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Caerus Medical
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No