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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 (MM-ZTE)

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown

Conditions

Multiple Myeloma
Bone Metastases

Treatments

Other: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05381077
2020/27JUL/380

Details and patient eligibility

About

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.

Full 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.).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 99 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)

30 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:
Other: MRI

Trial contacts and locations

1

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Central trial contact

perrine Triqueneaux; Frederic Lecouvet, MD-PhD

Data sourced from clinicaltrials.gov

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