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

Not Applicable

Not yet recruiting

• Conditions: Multiple Myeloma Bone Disease

• Registration Number: NCT06988020
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Study Start: 2025-06
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic performance of the different imaging protocols	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols	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.

Trial Locations

Locations (2)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium