Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With 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.
Procedure: magnetic resonance imaging
Procedure: sentinel lymph node biopsy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase II Study of Combidex in Axillary Node Staging in Breast Cancer|
- Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Changes in MR T1 and T2 signal intensity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107484
|United States, Virginia|
|Massey Cancer Center at Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Karen A. Kurdziel, MD||Massey Cancer Center|