"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma (MM-ZTE-II)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Multiple Myeloma Bone Disease

Treatments: Device: MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06988020

2025/13FEV/071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Whole body MRI

Other group

Description:

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

Treatment:

Device: MRI