NCT00107484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

May 3, 2010

Status Verified

April 1, 2010

Enrollment Period

1.1 years

First QC Date

April 5, 2005

Last Update Submit

April 30, 2010

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancermale breast cancer

Outcome Measures

Primary Outcomes (1)

  • Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes

    2 years

Secondary Outcomes (1)

  • Changes in MR T1 and T2 signal intensity

    2 years

Interventions

ferumoxtran-10DRUG
magnetic resonance imagingPROCEDURE
sentinel lymph node biopsyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

ferumoxtran-10Magnetic Resonance SpectroscopySentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node Excision

Study Officials

  • Karen A. Kurdziel, MD

    Massey Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 5, 2005

First Posted

April 6, 2005

Study Start

September 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

May 3, 2010

Record last verified: 2010-04

Locations

US(1)