Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
- Determine the utility of magnetic resonance (MR) imaging using ferumoxtran-10 in
identifying metastases to the axillary lymph nodes in patients with invasive breast
- 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
Karen A. Kurdziel, MD
Massey Cancer Center
United States: Federal Government
|Massey Cancer Center at Virginia Commonwealth University||Richmond, Virginia 23298-0037|