Multiple Myeloma Bone DiseaseMM-ZTE-IINCT06988020
"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma
A study testing MRI in people with Multiple Myeloma Bone Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Bone Disease
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Apr 2025to Nov 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
- Patient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.
- Recurrent patient after intensive treatment (high dose chemotherapy, bone marrow transplant, etc.).
- Patient requiring a PET / CT considered as the technique of choice in these stages of the disease.
Who cannot join
- Implanted material incompatible with MRI.
- Severe claustrophobia.
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Perrine Triqueneaux contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels
Frédéric Lecouvet, +3227642793, frederic.lecouvet@saintluc.uclouvain.be
Perrine Triqueneaux, perrine.triqueneaux@saintluc.uclouvain.be
About this study
Official title: Evaluation of Optimised Whole-body MRI Examinations Incorporating "Pseudo-scanner" Sequences (ZTE, "Zero Echo Time" AND Lava Flex) for the Detection of Bone Lesions in Multiple Myeloma
Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single non-irradiating imaging examination. Since the preliminary work mentioned above, optimizations have been made to the pseudo-CT sequences, including the addition of deep learning (correcting noise in the images) and the correction of chemical shift artifact (linked to the coexistence of hydrated tissue and fatty tissue), which carry real hope of improving their diagnostic potential and accuracy.
Read the detailed description
Currently recommended imaging techniques for detecting bone lesions include whole-body MRI (WB-MRI), computed tomography (CT), and PET-CT. WB-MRI and PET-CT outperform CT for assessing treatment response, with WB-MRI already being the imaging modality of choice in many countries. However WB-MRI, the technique of choice for detecting bone marrow involvement, does not allow visualization of mineral bone, limiting its ability to accurately assess osteolysis. Zero Echo Time (ZTE) and Lava Flex Low Flip Angle (LF) MRI sequences represent a major advance, providing visualization of tissues at very short T2 relaxation times with resolution close to that of CT. These new sequences (known as pseudo-CT or pseudo-CT) offer for the first time the opportunity to study mineral bone by MRI, thus considerably increasing the diagnostic potential of this modality in MM.
- Conditions
- Multiple Myeloma Bone Disease
- Being tested
- MRI
- Keywords
- bone, imaging, mri, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Whole body MRI including ZTE sequences
| Study group | Role | What they receive |
|---|---|---|
| Whole body MRI | Other | There is only one cohort where each patient have the standard of care follow up (PET/CT) and Whole body MRI- ZTE sequence for the study Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the diagnostic performance of the different imaging protocols
The diagnostic performance of the different imaging protocols will be evaluated by analyzing the receptor efficiency function (ROC curve) and by estimating the Sensitivity (Se), Specificity (Sp), Positive Predictive Value (PPV), Negative Predictive Value (NPV) ) as well as the Predictive Accuracy (Acc) of the different imaging protocols.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols
McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start22 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma Bone DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
- Investigators
- Frédéric Lecouvet, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988020
- Sponsor's protocol ID
- 2025/13FEV/071
- Acronym
- MM-ZTE-II
- Status last verified
- Apr 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethic reason
Publications
Lecouvet FE, Zan D, Lepot D, Chabot C, Vekemans MC, Duchene G, Chiabai O, Triqueneaux P, Kirchgesner T, Taihi L, Poujol J, Gheysens O, Michoux N. MRI-based Zero Echo Time and Black Bone Pseudo-CT Compared with Whole-Body CT to Detect Osteolytic Lesions in Multiple Myeloma. Radiology. 2024 Oct;313(1):e231817. doi: 10.1148/radiol.231817.
PubMed 39377681Lecouvet FE, Vande Berg BC, Malghem J, Maldague BE. Magnetic resonance and computed tomography imaging in multiple myeloma. Semin Musculoskelet Radiol. 2001;5(1):43-55. doi: 10.1055/s-2001-12920.
PubMed 11371335Lecouvet FE, Boyadzhiev D, Collette L, Berckmans M, Michoux N, Triqueneaux P, Pasoglou V, Jamar F, Vekemans MC. MRI versus 18F-FDG-PET/CT for detecting bone marrow involvement in multiple myeloma: diagnostic performance and clinical relevance. Eur Radiol. 2020 Apr;30(4):1927-1937. doi: 10.1007/s00330-019-06469-1. Epub 2019 Dec 16.
PubMed 31844960
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optimised Whole-body MRI Examinations Incorporating "Pseudo-scanner" Sequences (ZTE, "Zero Echo Time" AND Lava Flex) for the Detection of Bone Lesions in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06988020
- Acronym / sponsor ID
- MM-ZTE-II / 2025/13FEV/071
- Conditions
- Multiple Myeloma Bone Disease
- Keywords
- bone, imaging, mri, multiple myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 May 2025 (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.
Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single non-irradiating imaging examination. Since the preliminary work mentioned above, optimizations have been made to the pseudo-CT sequences, including the addition of deep learning (correcting noise in the images) and the correction of chemical shift artifact (linked to the coexistence of hydrated tissue and fatty tissue), which carry real hope of improving their diagnostic potential and accuracy.
Detailed description
Currently recommended imaging techniques for detecting bone lesions include whole-body MRI (WB-MRI), computed tomography (CT), and PET-CT. WB-MRI and PET-CT outperform CT for assessing treatment response, with WB-MRI already being the imaging modality of choice in many countries. However WB-MRI, the technique of choice for detecting bone marrow involvement, does not allow visualization of mineral bone, limiting its ability to accurately assess osteolysis. Zero Echo Time (ZTE) and Lava Flex Low Flip Angle (LF) MRI sequences represent a major advance, providing visualization of tissues at very short T2 relaxation times with resolution close to that of CT. These new sequences (known as pseudo-CT or pseudo-CT) offer for the first time the opportunity to study mineral bone by MRI, thus considerably increasing the diagnostic potential of this modality in MM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole body MRI | Other | Device: MRIThere is only one cohort where each patient have the standard of care follow up (PET/CT) and Whole body MRI- ZTE sequence for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.
- Recurrent patient after intensive treatment (high dose chemotherapy, bone marrow transplant, etc.).
- Patient requiring a PET / CT considered as the technique of choice in these stages of the disease.
Key exclusion criteria (3 listed)
- Implanted material incompatible with MRI.
- Severe claustrophobia.
- Pregnant women
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 |
|---|---|---|
| MRIWhole body MRI including ZTE sequences | Device | Whole body MRI |
Primary outcome
Evaluation of the diagnostic performance of the different imaging protocols
Time frame: through study completion, an average of 1 year
The diagnostic performance of the different imaging protocols will be evaluated by analyzing the receptor efficiency function (ROC curve) and by estimating the Sensitivity (Se), Specificity (Sp), Positive Predictive Value (PPV), Negative Predictive Value (NPV) ) as well as the Predictive Accuracy (Acc) of the different imaging protocols.
1 secondary outcome
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols
Time frame: through study completion, an average of 1 year
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 24 Apr 2026.
- Background: PubMed 39377681Lecouvet FE, Zan D, Lepot D, Chabot C, Vekemans MC, Duchene G, Chiabai O, Triqueneaux P, Kirchgesner T, Taihi L, Poujol J, Gheysens O, Michoux N. MRI-based Zero Echo Time and Black Bone Pseudo-CT Compared with Whole-Body CT to Detect Osteolytic Lesions in Multiple Myeloma. Radiology. 2024 Oct;313(1):e231817. doi: 10.1148/radiol.231817.
- Background: PubMed 11371335Lecouvet FE, Vande Berg BC, Malghem J, Maldague BE. Magnetic resonance and computed tomography imaging in multiple myeloma. Semin Musculoskelet Radiol. 2001;5(1):43-55. doi: 10.1055/s-2001-12920.
- Background: PubMed 31844960Lecouvet FE, Boyadzhiev D, Collette L, Berckmans M, Michoux N, Triqueneaux P, Pasoglou V, Jamar F, Vekemans MC. MRI versus 18F-FDG-PET/CT for detecting bone marrow involvement in multiple myeloma: diagnostic performance and clinical relevance. Eur Radiol. 2020 Apr;30(4):1927-1937. doi: 10.1007/s00330-019-06469-1. Epub 2019 Dec 16.
- Individual participant dataSharing planned: No. Ethic reason
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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.
Perrine Triqueneaux contact
Frédéric Lecouvet 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 Multiple Myeloma Bone Disease, 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 3 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 24 Apr 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 Lecouvet (+3227642793, 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?
Evaluation of the diagnostic performance of the different imaging protocols (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988020, which also lists 3 linked publications.
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 24 Apr 2026.