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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00107484
First received: April 5, 2005
Last updated: April 30, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Breast Cancer
Drug: ferumoxtran-10
Procedure: magnetic resonance imaging
Procedure: sentinel lymph node biopsy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Study of Combidex in Axillary Node Staging in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in MR T1 and T2 signal intensity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: September 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Male or female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • 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

Hepatic

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

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 30 days since prior investigational agents
  • More than 3 months since prior ferumoxides
  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: NCT00107484

Locations
United States, Virginia
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Chair: Karen A. Kurdziel, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Martha Wellons, Massey Cancer Center
ClinicalTrials.gov Identifier: NCT00107484     History of Changes
Other Study ID Numbers: CDR0000420833, P30CA016059, MCV-4141, NCI-7029
Study First Received: April 5, 2005
Last Updated: April 30, 2010
Health Authority: United States: Federal Government

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
Neoplasms
Breast Diseases
Skin Diseases
Ferumoxtran-10
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014