Creation of a Clinical Database of Lumbar Spine MRI

NCT ID: NCT06248827

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-04-30

Brief 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 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 :

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.

Conditions

Low Back Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Data Collection

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

Caerus Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

David Vittecoq

Role: CONTACT

dvittecoq@caerusmedical.com

0033650385980

Other Identifiers

CM-01

Identifier Type: -

Identifier Source: org_study_id