Multicentre Evaluation of Spinal Bone Pathologies Using Zero Echo Time (ZTE) Pseudo-CT MRI Sequences: a Clinical Implementation Study (MULTILUMBAR)
Innovative sequences known as "pseudo-CT"-such as Ultrashort Echo Time (UTE) and Zero Echo Time (ZTE)-enable good visualization of mineralized bone. These new sequences appear to enhance MRI performance in the detection of fractures, spondylolysis, and other bone abnormalities.
We would like to offer patients referred for a CT scan due to lumbar spine bone pathology the option of undergoing an MRI study, in order to compare the performance of the two techniques.
Study Overview
Detailed Description
Magnetic resonance imaging (MRI) is the gold-standard modality for examining the bone marrow and soft tissues of the spine, thanks to its excellent contrast resolution. It enables precise visualization of the intervertebral discs, nerve roots, and spinal cord. However, its ability to visualize bone mineral remains limited due to the rapid decay of the T2 signal and the inability of conventional sequences to capture signals from tissues with very short relaxation times. Consequently, assessing bone structures-such as cortical or trabecular bone, osteophytes, or fractures-remains challenging, particularly in cases of complex pathologies.
Innovative sequences known as "pseudo-CT" sequences-such as Ultrashort Echo Time (UTE) and Zero Echo Time (ZTE)-enable the capture of signals from tissues with very short T2 relaxation times and provide good visualization of mineralized bone. These new sequences appear to enhance MRI performance in the detection of fractures, spondylolysis, and other bone abnormalities.
Despite the promising potential of "pseudo-CT" sequences, studies comparing them to conventional CT and MRI sequences remain limited, as do data regarding their overall clinical benefit. Further research is therefore needed to evaluate their diagnostic value, their ability to improve patient management, and their potential to reduce the need for other imaging examinations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Frédéric Emmanuel Lecouvet, MD-PhD
- Phone Number: 003227642793
- Email: frederic.lecouvet@saintluc.uclouvain.be
Study Contact Backup
- Name: Perrine Elizabeth Triqueneaux, Msc
- Phone Number: 003227642935
- Email: perrine.triqueneaux@saintluc.uclouvain.be
Study Locations
-
-
-
Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint Luc
-
Contact:
- Frédéric E Lecouvet, MD-PhD
- Phone Number: 003227642793
- Email: frederic.lecouvet@saintluc.ucouvain.be
-
Contact:
- Perrine E Triqueneaux, Msc
- Email: perrine.triqueneaux@saintluc.uclouvain.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults requiring a CT scan as part of their clinical assessment for lumbar spine imaging who also provide informed consent to participate in the study.
- Patients presenting with acute or chronic low back pain and requiring a CT scan for diagnostic purposes.
Exclusion Criteria:
- Contraindications to MRI, such as pacemakers, metal implants, severe claustrophobia, or pregnancy
- Spinal surgery within the last six months.
- Patients who cannot or do not wish to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All patients
Each patient has a lumbar spine CT scan scheduled as part of their clinical follow-up. We are adding a lumbar spine MRI for the purposes of the study. |
Lumbar spine MRI using innovative sequences known as "pseudo-CT," enabling the capture of signals from tissues with very short T2 relaxation times and providing good visualization of mineralized bone. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sensitivity and specificity of pseudo-CT MRI
Time Frame: One MRI of 30 min
|
To evaluate the sensitivity and specificity of pseudo-CT MRI for the detection of bone lesions. |
One MRI of 30 min
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frédéric E Lecouvet, MD-PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/05MAI/177
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.