Status:
COMPLETED
Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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. Se...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00107484
Start Date
September 1 2005
End Date
October 1 2006
Last Update
May 3 2010
Active Locations (1)
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1
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037