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

April 30, 2010 updated by: Virginia Commonwealth University

Phase II Study of Combidex in Axillary Node Staging in Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Virginia
  - Richmond, Virginia, United States, 23298-0037
    - Massey Cancer Center at Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in MR T1 and T2 signal intensity Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Karen A. Kurdziel, MD, Massey Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)