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

NCT ID: NCT00107484

Last Updated: 2010-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-10-31

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 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.

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

ferumoxtran-10

Intervention Type: DRUG

magnetic resonance imaging

Intervention Type: PROCEDURE

sentinel lymph node biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Massey Cancer Center

Principal Investigators

Karen A. Kurdziel, MD

Role: STUDY_CHAIR

Massey Cancer Center

Locations

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCV-4141

Identifier Type: -

Identifier Source: secondary_id

NCI-7029

Identifier Type: -

Identifier Source: secondary_id

CDR0000420833

Identifier Type: -

Identifier Source: org_study_id