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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
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

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

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Multiple Myeloma and that are referred for PET CT imaging.
Criteria

Inclusion Criteria

  • subjects who are schedule for PET CT
  • subjects that are diagnosed with Multiple Myeloma.
  • Healthy subjects will be enrolled to optimize imaging techniques
  • subjects 30 - 80 years of age

Exclusion Criteria:

Exclusion criteria include all patients who are contraindicated for MR imaging in general.

Contraindications include:

  • electrical implants such as cardiac pacemakers or perfusion pumps
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • ferromagnetic objects such as jewelry or metal clips in clothing
  • pregnant subjects
  • pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.

Information from the National Library of Medicine

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


Locations
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United States, New York
NYU Center for Biomedical Imaging
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Sandra L Moore, MD NYU School of Medicine

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01880762     History of Changes
Other Study ID Numbers: S12-02920
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Keywords provided by NYU Langone Health:
PET MR development and validation
Additional relevant MeSH terms:
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Multiple Myeloma
Osteoporosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases