"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma

NCT ID: NCT06988020

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-11-30

Brief 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 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.

Conditions

Multiple Myeloma Bone Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Whole body MRI

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

Group Type: OTHER

MRI

Intervention Type: DEVICE

Whole body MRI including ZTE sequences

Interventions

MRI

Whole body MRI including ZTE sequences

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• Implanted material incompatible with MRI.
• Severe claustrophobia.
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Electric

INDUSTRY

Sponsor Role: collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Lecouvet

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Central Contacts

Frédéric Lecouvet

Role: CONTACT

frederic.lecouvet@saintluc.uclouvain.be

+3227642793

Perrine Triqueneaux

Role: CONTACT

perrine.triqueneaux@saintluc.uclouvain.be

Facility Contacts

Frederic Emmanuel Lecouvet, Md PhD

Role: primary

frederic.lecouvet@saintluc.uclouvain.be

+3227652793

Perrine Triqueneaux, Msc

Role: backup

perrine.triqueneaux@saintluc.uclouvain.be

027642935

Frédéric Lecouvet

Role: primary

frederic.lecouvet@saintluc.uclouvain.be

+3227642793

Perrine Triqueneaux

Role: backup

perrine.triqueneaux@saintluc.uclouvain.be

References

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.

Reference Type: BACKGROUND

PMID: 39377681 (View on PubMed)

Lecouvet 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.

Reference Type: BACKGROUND

PMID: 11371335 (View on PubMed)

Lecouvet 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.

Reference Type: BACKGROUND

PMID: 31844960 (View on PubMed)

Other Identifiers

2025/13FEV/071

Identifier Type: -

Identifier Source: org_study_id