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)

May 12, 2022 updated by: Lecouvet, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
Other: MRI
Whole body MRI (ZTE sequence)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Frederic Lecouvet, MD-PhD, Cliniques Universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2021

Primary Completion (ANTICIPATED)

August 31, 2023

Study Completion (ANTICIPATED)

August 31, 2023

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 12, 2022

First Posted (ACTUAL)

May 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/27JUL/380

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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