"Pseudo-scanner" MRI Sequences for the Detection of Bone Lesions in Multiple Myeloma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

Recent work has confirmed the diagnostic performance of pseudo-CT sequences for detecting osteolytic lesions. Their integration into whole body MRI (WB MRI) could transform the diagnostic approach to MM, by allowing a combined assessment of bone marrow involvement, tissue viability and osteolysis, during a single non-irradiating imaging examination. Since the preliminary work mentioned above, optimizations have been made to the pseudo-CT sequences, including the addition of deep learning (correcting noise in the images) and the correction of chemical shift artifact (linked to the coexistence of hydrated tissue and fatty tissue), which carry real hope of improving their diagnostic potential and accuracy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Implanted material incompatible with MRI.

Severe claustrophobia.

Pregnant women

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI

    Device

    Whole body MRI including ZTE sequences

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Whole body MRIOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.