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Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00107484
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : May 3, 2010
National Cancer Institute (NCI)
Information provided by:
Virginia Commonwealth University

Brief Summary:

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary lymph nodes and may help in planning breast cancer treatment.

PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ferumoxtran-10 Procedure: magnetic resonance imaging Procedure: sentinel lymph node biopsy Phase 2

Detailed Description:



  • Determine the utility of magnetic resonance (MR) imaging using ferumoxtran-10 in identifying metastases to the axillary lymph nodes in patients with invasive breast cancer.


  • Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after administration of this drug to these patients.
  • Determine the potential of delayed imaging, in terms of defining tumor boundaries, in these patients.

OUTLINE: Patients receive ferumoxtran-10 IV over 25-30 minutes on day 0 in the absence of unacceptable toxicity. Patients undergo MRI of the involved breast and ipsilateral axilla on day 0 (once before and once after ferumoxtran-10 administration) and then once on day 1.

Within 3 weeks after the completion of imaging studies, patients undergo sentinel lymph node biopsy. If the sentinel node is positive for malignancy on touch prep, an axillary lymph node dissection is performed if clinically indicated.

Patients are followed at approximately 1 month after surgery.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 8.3 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
Study Start Date : September 2005
Primary Completion Date : October 2006
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Changes in MR T1 and T2 signal intensity [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed invasive breast cancer
  • Candidate for sentinel lymph node biopsy and/or axillary lymph node dissection
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Ferritin ≤ 350 ng/mL*
  • Transferrin saturation level ≤ 40%* NOTE: *Patients with lab values above these limits may be eligible provided there is no hemochromatosis by hematology consultation


  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Alkaline phosphatase normal
  • PT normal
  • Albumin normal
  • No history of cirrhosis


  • Creatinine normal OR
  • Creatinine clearance > 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Medically stable
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
  • No history of allergic reaction to any contrast media
  • No immunodeficiency that would predispose patient to a specific or non-specific mediator release
  • No contraindication to MRI, including any of the following:

    • Severe claustrophobia
    • Pacemaker
    • Aneurysm clips
    • Defibrillators
    • Certain types of replacement joints
    • Other institutional contraindication to MRI
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 30 days since prior investigational agents
  • More than 3 months since prior ferumoxides

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): NCT00107484

United States, Virginia
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Study Chair: Karen A. Kurdziel, MD Massey Cancer Center

Responsible Party: Martha Wellons, Massey Cancer Center
ClinicalTrials.gov Identifier: NCT00107484     History of Changes
Other Study ID Numbers: CDR0000420833
P30CA016059 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2005    Key Record Dates
Last Update Posted: May 3, 2010
Last Verified: April 2010

Keywords provided by Virginia Commonwealth University:
stage IV breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases