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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: ferumoxtran-10
* Procedure: magnetic resonance imaging
* Procedure: sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ferumoxtran-10|nan|
|Procedure: magnetic resonance imaging|nan|
|Procedure: sentinel lymph node biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in MR T1 and T2 signal intensity |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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