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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)

Primary Purpose

Multiple Myeloma, Bone Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring MRI, Zero time echo

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cliniques Universaires Siant LucRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Whole body MRI

Arm 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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2022
Last Updated
May 12, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05381077
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Bone Metastases
Keywords
MRI, Zero time echo

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Whole body MRI in addition to the classic PET / CT assessment for all participant.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole body MRI
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Whole body MRI (ZTE sequence)
Primary Outcome Measure Information:
Title
Evaluation of the diagnostic performance of the different imaging protocols
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Comparison of Sensitivity (Se) and Predictive Precision (Acc) of the different imaging protocols
Description
McNemar test on paired data. The Gold Standard will be determined by a panel of independent experts based on all available imaging techniques.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic Lecouvet, MD-PhD
Phone
+3227642793
Email
frederic.lecouvet@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
perrine Triqueneaux
Phone
+3227642935
Email
perrine.triqueneaux@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Lecouvet, MD-PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universaires Siant Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Lecouvet, MD-PhD
Phone
+3227642793
Email
frederic.lecouvet@uclouvain.be

12. IPD Sharing Statement

Learn more about this trial

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

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