Magnetic Resonance Imaging Using Ferumoxtran-10 in Finding Metastases to the Axillary Lymph Nodes in Patients With Breast Cancer

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: ferumoxtran-10

Procedure: sentinel lymph node biopsy

Procedure: magnetic resonance imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00107484

MCV-4141

NCI-7029

CDR0000420833

P30CA016059 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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