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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016059 | U.S. NIH Grant/Contract | View source | |
| MCV-4141 | |||
| NCI-7029 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferumoxtran-10 | Drug | |||
| magnetic resonance imaging | Procedure | |||
| sentinel lymph node biopsy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in MR T1 and T2 signal intensity | 2 years |
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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:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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:
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Karen A. Kurdziel, MD | Massey Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massey Cancer Center at Virginia Commonwealth University | Richmond | Virginia | 23298-0037 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C097921 | ferumoxtran-10 |
| D009682 | Magnetic Resonance Spectroscopy |
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
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