A Phase 2 interventional study of ferumoxtran-10 and magnetic resonance imaging in Breast Cancer, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-03.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 3 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No contraindication to MRI, including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
Time frame: 2 years
Changes in MR T1 and T2 signal intensity
Time frame: 2 years
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University