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NCT Number: NCT06988020

"Pseudo-scanner" MRI Sequences 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location status: Recruiting

Location contact

Frédéric Lecouvet

CONTACT

[email protected]

+3227642793

Frédéric Lecouvet

PRINCIPAL_INVESTIGATOR

Perrine Triqueneaux

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

Whole body MRI including ZTE sequences

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Lecouvet

CONTACT

[email protected]

+3227642793

Perrine Triqueneaux

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • General Electric

Registry information

Official study 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

Acronym: MM-ZTE-II

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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