NCT05381077

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-myeloma

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

May 4, 2022

Last Update Submit

May 12, 2022

Conditions

Multiple MyelomaBone Metastases

Keywords

MRIZero time echo

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Whole body MRI

OTHER

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

Interventions

MRIOTHER

Whole body MRI (ZTE sequence)

Whole body MRI

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Implanted material incompatible with MRI.
  • Severe claustrophobia.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universaires Siant Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40388042DERIVED

  • 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.

    PMID: 39377681DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Frederic Lecouvet, MD-PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Lecouvet, MD-PhD

CONTACT

+3227642793frederic.lecouvet@uclouvain.be

perrine Triqueneaux

CONTACT

+3227642935perrine.triqueneaux@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Whole body MRI in addition to the classic PET / CT assessment for all participant.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 19, 2022

Study Start

February 2, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

BE(1)