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

Multiple Myeloma Clinical Trial

— MM-ZTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381077
• Other study ID #: 2020/27JUL/380
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Frederic Lecouvet, MD-PhD
• Phone: +3227642793
• Email: frederic.lecouvet[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• MRI
Whole body MRI (ZTE sequence)

Locations

Country	Name	City	State
Belgium	Cliniques Universaires Siant Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the diagnostic performance of the different imaging protocols	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.	through study completion, an average of 1 year
Primary	Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols	McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.	through study completion, an average of 1 year