Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: ferumoxtran-10 Procedure: magnetic resonance imaging Procedure: sentinel lymph node biopsy |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 3 |
| Study Start Date: | September 2005 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Martha Wellons, Massey Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00107484 History of Changes |
| Other Study ID Numbers: | CDR0000420833, P30CA016059, MCV-4141, NCI-7029 |
| Study First Received: | April 5, 2005 |
| Last Updated: | April 30, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Virginia Commonwealth University:
|
stage IV breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer male breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013