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

NCT ID: NCT05381077

Last Updated: 2022-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2023-08-31

Brief Summary

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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

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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.).

Conditions

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Multiple Myeloma Bone Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Whole body MRI in addition to the classic PET / CT assessment for all participant.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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 OTHER

Whole body MRI (ZTE sequence)

Interventions

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MRI

Whole body MRI (ZTE sequence)

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Lecouvet

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederic Lecouvet, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universaires Siant Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Frederic Lecouvet, MD-PhD

Role: CONTACT

+3227642793

perrine Triqueneaux

Role: CONTACT

+3227642935

Facility Contacts

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Frederic Lecouvet, MD-PhD

Role: primary

+3227642793

References

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Chabot C, Haegeman M, Chaouch E, Dumitriu D, Menten R, Steenhaut P, Bernard P, Triqueneaux P, Michoux N, Lecouvet FE. MRI-based pseudo-CT sequences as a radiation-free alternative to CT for obstetric pelvimetry: a proof-of-concept study. Eur Radiol Exp. 2025 May 19;9(1):52. doi: 10.1186/s41747-025-00585-y.

Reference Type DERIVED
PMID: 40388042 (View on PubMed)

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 DERIVED
PMID: 39377681 (View on PubMed)

Other Identifiers

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2020/27JUL/380

Identifier Type: -

Identifier Source: org_study_id

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