Clinical Implication of Bone Marrow Perfusion Patterns Imaged by Dynamic MRI in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00166855
Recruitment Status : Unknown
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : November 24, 2005
Information provided by:
National Taiwan University Hospital

Brief Summary:

Background: Multiple myeloma (MM) is a clonal plasma cell neoplasm characterized by proliferation of neoplastic plasma cells in bone marrow (BM). So far, it is an incurable disease and the median survival time of MM patients is only three to four years. Till now, whether the extent of angiogenesis in BM of MM patients serves as an important and independent prognostic factor is still debated. In this study, we would like to have the BM perfusion status imaged by dynamic MRI to mimic the macroscopic vascular densities of BM, and thereafter, the BM perfusion status, the clinical outcome of the MM patients, and the angiogenesis related biological markers will be correlated.

Methods: About 35 to 50 MM patients, included newly diagnosed patients or the patients who will undertake the special treatment, are enrolled in this study. The thoraco-lumbar spine is scanned by the MRI, and the BM perfusion status is obtained by contrast-enhanced dynamic MRI. Meanwhile, the patients undertake BM biopsy at one site or two sites and the BM aspirates are also obtained and separated into BM plasma and BM mononuclear cells (BMMC) by Ficoll-Hypaque centrifugation. The angiogenesis related genes expression profiles of the BMMC will be determined by cDNA microarrays and some of them, like VEGF, bFGF, and PDGF, will be semiquantified by real-time PCR. The levels of related proteins will be determined by ELISA. The BM plasma samples are further applied to proteomic analysis to screen the novel molecules with clinical relevance.

Prospects: BM perfusion patterns imaged by dynamic MRI can predict the clinical outcome of MM, and are correlated with the angiogenesis relevant biological markers in BM.

Condition or disease Intervention/treatment Phase
Multiple Myeloma, Newly Diagnosed Procedure: dynamic MRI and bone marrow sampling Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2005
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. treatment response

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:multiple myeloma, newly diagnosed -

Exclusion Criteria:nil, except for the patients disagree MRI study nor bone marrow sampling

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 identifier (NCT number): NCT00166855

Contact: Shang-Yi Huang, M.D. 886-2-23123456 ext 3629

National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shang-Yi Huang, M.D.    886-2-23123456 ext 3629   
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Shang-Yi Huang, M.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan Identifier: NCT00166855     History of Changes
Other Study ID Numbers: 9361701200
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 24, 2005
Last Verified: May 2005

Keywords provided by National Taiwan University Hospital:
bone marrow perfusion
dynamic MRI
multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases