Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions
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|ClinicalTrials.gov Identifier: NCT01880762|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : December 2, 2016
Developing an MRI protocol at 1.5 T allowing quantification of the hematopoietic, fatty and trabecular moieties of marrow. An ideal protocol would differentiate red marrow from neoplastic cellular infiltration, and detect loss of trabecular bone. This study assesses the feasibility of a multiple gradient echo sequence for differentiation of water and fat constituents of marrow, combined with T2* mapping to interrogate the trabecular component The investigators hypothesize that these techniques will allow better identification of lesion type than routine MR sequences, and can be used to quantitatively characterize myelomatous marrow replacement, with iliac crest biopsy (which is routinely performed in the diagnosis of myeloma) as gold standard.
Fluoro-deoxyglucose (FDG)/PET CT imaging can detect FDG uptake in active myeloma and is obtained routinely for certain cohorts of patients with myeloma. PET/CT is commonly used in both initial whole body assessment and in monitoring remission. PET has been found to be about 59% sensitive and 75% specific for detection of myeloma .
Myelomatous lesions are detected on MRI by the replacement of marrow fat. Routine MRI however is limited by scope/field of view, usually evaluating marrow in a single anatomic region (such as an extremity, the pelvis or spine). To assess the diffuse marrow involvement in MM, whole body MRI imaging potentiates near global assessment of the marrow, which aids in evaluating tumor burden, and may be useful in staging.
|Condition or disease|
|Multiple Myeloma Disease of the Marrow Osteoporosis|
Imaging of the pelvis and bilateral femora at 1.5 Tesla in a 30 minute research time "slots" at NYU-FPO MRI, Tisch Hospital, NYU Medical Center, Department of Radiology, HCC basement. This protocol utilizes routine, Dixon sequences and multi-echo MR "spectroscopic" sequences, allowing quantization of the fat water and trabecular moieties of marrow. The opposed phase portion of a Dixon sequence can aid differentiation between dense red marrow and a metastatic deposits by assaying for intravoxel fat. Diffusion sequences may also potentially improve specificity by assessing mobility of water in hypercellular and hypocellular portions of marrow, and will be added to the protocol if scan time permits.
The new sequences conform to FDA safety regulations regarding static magnetic field, time varying magnetic fields, specific absorption rate, and acoustic noise levels. However, since they have not been fully validated for diagnostic accuracy, the resulting images will be analyzed for research purposes only and will not be used in the patient's diagnostic assessment.
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Research Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
- To Improve specificity of Multiple Myeloma using PET MR [ Time Frame: 2 years ]WHOLE BODY MRI/PET imaging for global assessment of the marrow in patients with MM. This will determine the feasibility of a multiple gradient echo sequence for differentiation of water and fat constituents of marrow, combined with T2* mapping to interrogate the trabecular component which would allow for increased identification of lesion type than routine MR Sequences, and can be used to quantitatively characterize myelomatous marrow replacement with the current biopsy as gold standard.
- Newly developed MRI imaging sequences [ Time Frame: 2 years ]New imaging sequences developed will further improve specificity and assessment of marrow diseases in multiple myeloma patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880762
|United States, New York|
|NYU Center for Biomedical Imaging|
|New York, New York, United States, 10016|
|Principal Investigator:||Sandra L Moore, MD||NYU School of Medicine|