Expired Study
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Richmond, Virginia 23298


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.


Study summary:

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.


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


NCT ID:

NCT00107484


Primary Contact:

Study Chair
Karen A. Kurdziel, MD
Massey Cancer Center


Backup Contact:

N/A


Location Contact:

Richmond, Virginia 23298
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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