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

Not Applicable

• Conditions: Multiple Myeloma; Bone Metastases
• Interventions: Other: MRI

• Registration Number: NCT05381077
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

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 Timeline

• Study Start: 2021-02-02
• Status Verified: 2022-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-12
• Last Update Submitted: 2022-05-12
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Arm && Interventions

Group	Intervention	Description
Whole body MRI	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

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.
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 (1)

Cliniques Universaires Siant Luc; 🇧🇪 Brussels, Belgium