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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Evaluation of Spinal Bone Pathologies Using Zero Echo Time (ZTE) Pseudo-CT MRI Sequences: a Clinical Implementation Study
- ClinicalTrials.gov ID
- NCT07844577
- Acronym / sponsor ID
- MULTILUMBAR / 2025/05MAI/177
- Conditions
- Lumbar Spine Pathology
- Keywords
- CT, MRI, Pseudo CT MRI sequences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: MRIEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRILumbar 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. | Device | All patients |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Lumbar Spine Pathology
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
RecruitingObservational study
Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Degenerative Arthropathy of Lumbar Spinal Facet Joint
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
Not yet recruiting
COMPARISON OF THE EFFECTS OF ERECTOR SPINAE PLANE (ESP) BLOCK AND QUADRO İLİAC PLANE (QIP) BLOCK ON POSTOPERATIVE OPIOID CONSUMPTION AND PAIN IN LUMBAR SPINAL SURGERY
Postoperative Pain Management
Not yet recruiting
Erector Spinae Plane Block for Chronic Pain After Spinal Surgery
Postoperative Pain, Chronic Postsurgical Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric E Lecouvet, MD-PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Emmanuel Lecouvet, MD-PhD (003227642793, frederic.lecouvet@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of pseudo-CT MRI (time frame: One MRI of 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.