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

NCT00166855 | Unknown

• 1 other identifier: 9361701200
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma, Newly Diagnosed

Keywords

angiogenesis; bone marrow perfusion; dynamic MRI; multiple myeloma; prognosis

Outcome Measures

Primary Outcomes (1)

• overall survival

Secondary Outcomes (1)

• treatment response

Interventions

dynamic MRI and bone marrow sampling PROCEDURE

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shang-Yi Huang, M.D.

  Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shang-Yi Huang, M.D.

CONTACT

886-2-23123456; sy551225@ms7.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: July 1, 2005
• Study Completion: July 1, 2009
• Last Updated: November 24, 2005

Record last verified: 2005-05

Locations

TW (1)