Creation of a Clinical Database of Lumbar Spine MRI

NCT06248827 | Not Yet Recruiting

• 1 other identifier: CM-01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

Low back pain; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Data annotation and developpment of artificial intelligence algorithms

  2 years

Study Arms (1)

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.

Other: Data Collection

Interventions

Data Collection 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

Lumbar Spine MRI exams

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Caerus Medical: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

David Vittecoq

CONTACT

0033650385980; dvittecoq@caerusmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08