Multiple MyelomaMM-ZTENCT05381077
Evaluation of Whole Body Examination by MRI Integrating the "Zero Time Eco" Sequence (ZTE, Pseudo-CT) for the Detection of Bone Lesions in Multiple Myeloma: Comparison With Pet / CT and Whole Body Scanner
A study testing MRI in people with Multiple Myeloma and Bone Metastases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To assess the added value of magnetic resonance imaging (MRI) of the skeleton compared to other validated techniques for the detection of bone lesions in patients with multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Myeloma, Bone Metastases
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Feb 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- 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.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universaires Siant Luc
Brussels, 1200
Frederic Lecouvet, MD-PhD, +3227642793, frederic.lecouvet@uclouvain.be
About this study
To assess the added value of magnetic resonance imaging (MRI) of the skeleton compared to other validated techniques for the detection of bone lesions in patients with multiple myeloma.
Read the detailed description
The aim of our study is to offer patients benefiting from a diagnostic approach to myeloma by PET / CT, a whole body MRI examination (MRI-CE) comprising, in addition to the "classic bone marrow" sequences, a ZTE sequence (see below) . This study is being undertaken to compare and assess the complementarity of imaging techniques in the diagnostic management of this disease.
The stages of the work will be:
Optimizing bone marrow exploration sequences by MRI (F. Lecouvet, N. Michoux, Gaetan Duchêne).
Develop and validate a whole body-wide new MRI sequence "ZTE" capable of detecting and quantifying disease-induced osteolysis in the skeleton.
Optimize the reconstruction of these images (Deep Learning software developed with the firm GE), training of the reconstruction of ZTE images by correlation with the scanner (F. Lecouvet, N. Michoux, Gaetan Duchêne).
This approach is completely original, never having been evaluated: the ZTE sequence is a recent development, made available at CUSL on the new research MRI magnet.
The addition of this sequence to the already major information provided by MRI for the detection of the disease and the evaluation of its response (method of choice, see below) would constitute a major advance in establishing the diagnostic value of this technique. non-irradiating compared to other techniques (PET-CT, low dose scanner, etc.).
- Conditions
- Multiple Myeloma, Bone Metastases
- Being tested
- MRI
- Keywords
- MRI, Zero time echo
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Whole body MRI (ZTE sequence)
| 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: Other: 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
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 posted19 May 2022
- Study start2 Feb 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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 MyelomaStudies 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
- Model description
- Whole body MRI in addition to the classic PET / CT assessment for all participant.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lecouvet, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Frederic Lecouvet, MD-PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381077
- Sponsor's protocol ID
- 2020/27JUL/380
- Acronym
- MM-ZTE
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lepot D, Chabot C, Duchene G, Mandava S, Fung M, Poujol J, Vekemans MC, Triqueneaux P, Watte N, Gheysens O, Michoux N, Lecouvet FE. Zero echo time MRI with deep learning reconstruction and chemical shift correction for detecting osteolytic myeloma lesions. Eur Radiol Exp. 2026 Jun 5;10(1):81. doi: 10.1186/s41747-026-00734-x.
PubMed 42247107Chabot C, Haegeman M, Chaouch E, Dumitriu D, Menten R, Steenhaut P, Bernard P, Triqueneaux P, Michoux N, Lecouvet FE. MRI-based pseudo-CT sequences as a radiation-free alternative to CT for obstetric pelvimetry: a proof-of-concept study. Eur Radiol Exp. 2025 May 19;9(1):52. doi: 10.1186/s41747-025-00585-y.
PubMed 40388042Lecouvet 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 39377681
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Whole Body Examination by MRI Integrating the "Zero Time Eco" Sequence (ZTE, Pseudo-CT) for the Detection of Bone Lesions in Multiple Myeloma: Comparison With Pet / CT and Whole Body Scanner
- ClinicalTrials.gov ID
- NCT05381077
- Acronym / sponsor ID
- MM-ZTE / 2020/27JUL/380
- Conditions
- Multiple Myeloma, Bone Metastases
- Keywords
- MRI, Zero time echo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 19 May 2022 (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.
To assess the added value of magnetic resonance imaging (MRI) of the skeleton compared to other validated techniques for the detection of bone lesions in patients with multiple myeloma.
Detailed description
The aim of our study is to offer patients benefiting from a diagnostic approach to myeloma by PET / CT, a whole body MRI examination (MRI-CE) comprising, in addition to the "classic bone marrow" sequences, a ZTE sequence (see below) . This study is being undertaken to compare and assess the complementarity of imaging techniques in the diagnostic management of this disease.
The stages of the work will be:
Optimizing bone marrow exploration sequences by MRI (F. Lecouvet, N. Michoux, Gaetan Duchêne).
Develop and validate a whole body-wide new MRI sequence "ZTE" capable of detecting and quantifying disease-induced osteolysis in the skeleton.
Optimize the reconstruction of these images (Deep Learning software developed with the firm GE), training of the reconstruction of ZTE images by correlation with the scanner (F. Lecouvet, N. Michoux, Gaetan Duchêne).
This approach is completely original, never having been evaluated: the ZTE sequence is a recent development, made available at CUSL on the new research MRI magnet.
The addition of this sequence to the already major information provided by MRI for the detection of the disease and the evaluation of its response (method of choice, see below) would constitute a major advance in establishing the diagnostic value of this technique. non-irradiating compared to other techniques (PET-CT, low dose scanner, etc.).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Whole body MRI in addition to the classic PET / CT assessment for all participant.
| Arm | Type | Receives |
|---|---|---|
| Whole body MRI | Other | Other: 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 to 99 years
- 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 (ZTE sequence) | Other | 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.
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols
Time frame: through study completion, an average of 1 year
McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 42247107Lepot D, Chabot C, Duchene G, Mandava S, Fung M, Poujol J, Vekemans MC, Triqueneaux P, Watte N, Gheysens O, Michoux N, Lecouvet FE. Zero echo time MRI with deep learning reconstruction and chemical shift correction for detecting osteolytic myeloma lesions. Eur Radiol Exp. 2026 Jun 5;10(1):81. doi: 10.1186/s41747-026-00734-x.
- Derived from this study: PubMed 40388042Chabot C, Haegeman M, Chaouch E, Dumitriu D, Menten R, Steenhaut P, Bernard P, Triqueneaux P, Michoux N, Lecouvet FE. MRI-based pseudo-CT sequences as a radiation-free alternative to CT for obstetric pelvimetry: a proof-of-concept study. Eur Radiol Exp. 2025 May 19;9(1):52. doi: 10.1186/s41747-025-00585-y.
- Derived from this study: 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.
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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. This study is not recruiting at the moment.
Frederic 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 Multiple Myeloma and Bone Metastases, 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: status not confirmed, as of the sponsor's last update on 19 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederic Lecouvet, MD-PhD (+3227642793, frederic.lecouvet@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). The study lists 2 primary outcomes in all. 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 NCT05381077, 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 19 May 2022.