Cliniques universitaires Saint-Luc
Brussels, Belgium
Location status: Recruiting
Location contact
Frédéric Lecouvet
CONTACT
Frédéric Lecouvet
PRINCIPAL_INVESTIGATOR
Perrine Triqueneaux
CONTACT
NCT Number: NCT06988020
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Brussels, Belgium
Location status: Recruiting
Frédéric Lecouvet
CONTACT
Frédéric Lecouvet
PRINCIPAL_INVESTIGATOR
Perrine Triqueneaux
CONTACT
Currently recommended imaging techniques for detecting bone lesions include whole-body MRI (WB-MRI), computed tomography (CT), and PET-CT. WB-MRI and PET-CT outperform CT for assessing treatment response, with WB-MRI already being the imaging modality of choice in many countries. However WB-MRI, the technique of choice for detecting bone marrow involvement, does not allow visualization of mineral bone, limiting its ability to accurately assess osteolysis. Zero Echo Time (ZTE) and Lava Flex Low Flip Angle (LF) MRI sequences represent a major advance, providing visualization of tissues at very short T2 relaxation times with resolution close to that of CT. These new sequences (known as pseudo-CT or pseudo-CT) offer for the first time the opportunity to study mineral bone by MRI, thus considerably increasing the diagnostic potential of this modality in MM.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient with newly diagnosed multiple myeloma, for whom bone imaging is required for staging.
Exclusion criteria
Whole body MRI including ZTE sequences
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.
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.
Contact information is provided by the study sponsor or research team.
Frédéric Lecouvet
CONTACT
Perrine Triqueneaux
CONTACT
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Other
Evaluation of Optimised Whole-body MRI Examinations Incorporating "Pseudo-scanner" Sequences (ZTE, "Zero Echo Time" AND Lava Flex) for the Detection of Bone Lesions in Multiple Myeloma
Acronym: MM-ZTE-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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