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Research Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions


N/A
30 Years
80 Years
Open (Enrolling)
Both
Multiple Myeloma, Disease of the Marrow, Osteoporosis

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Trial Information

Research Evaluation of PET/MR and PET/CT Imaging for Bone Marrow Lesions


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To Improve specificity of Multiple Myeloma using PET MR

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sandra L Moore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NYU School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

S12-02920

NCT ID:

NCT01880762

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Disease of the Marrow
  • Osteoporosis
  • PET MR development and validation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Osteoporosis

Name

Location
NYU Center for Biomedical Imaging New York, New York  10016