Lumbar Spine PathologyMULTILUMBARNCT07844577
Multicentre Evaluation of Spinal Bone Pathologies Using Zero Echo Time (ZTE) Pseudo-CT MRI Sequences: a Clinical Implementation Study
A study testing MRI in people with Lumbar Spine Pathology, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Pathology
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Apr 2026to 30 Mar 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
Frédéric E Lecouvet, MD-PhD, 003227642793, frederic.lecouvet@saintluc.ucouvain.be
Perrine E Triqueneaux, Msc, perrine.triqueneaux@saintluc.uclouvain.be
About this study
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.
Read the 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.
- Conditions
- Lumbar Spine Pathology
- Being tested
- MRI
- Keywords
- CT, MRI, Pseudo CT MRI sequences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | 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. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of pseudo-CT MRI
To evaluate the sensitivity and specificity of pseudo-CT MRI for the detection of bone lesions.
Measured: One MRI of 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start15 Apr 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine PathologyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will undergo the same procedure: a CT scan scheduled for their clinical follow-up, supplemented by an MRI performed for the purposes of the study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric E Lecouvet, MD-PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844577
- Sponsor's protocol ID
- 2025/05MAI/177
- Acronym
- MULTILUMBAR
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No