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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166855
First received: September 12, 2005
Last updated: November 23, 2005
Last verified: May 2005
  Purpose

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 Intervention
Multiple Myeloma, Newly Diagnosed
Procedure: dynamic MRI and bone marrow sampling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • treatment response

Estimated Enrollment: 40
Study Start Date: July 2005
Estimated Study Completion Date: July 2009
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:multiple myeloma, newly diagnosed -

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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166855

Contacts
Contact: Shang-Yi Huang, M.D. 886-2-23123456 ext 3629 sy551225@ms7.hinet.net

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shang-Yi Huang, M.D.    886-2-23123456 ext 3629    sy551225@ms7.hinet.net   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shang-Yi Huang, M.D. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166855     History of Changes
Other Study ID Numbers: 9361701200
Study First Received: September 12, 2005
Last Updated: November 23, 2005
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Multiple Myeloma
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

ClinicalTrials.gov processed this record on July 23, 2014