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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ferumoxtran-10

magnetic resonance imaging

sentinel lymph node biopsy

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massey Cancer Center at Virginia Commonwealth University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in MR T1 and T2 signal intensity

Full Information

NCT ID

NCT00107484

First Posted

April 5, 2005

Last Updated

April 30, 2010

Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00107484

Brief Title

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

Official Title

Phase II Study of Combidex in Axillary Node Staging in Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Virginia Commonwealth University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ferumoxtran-10

Intervention Type

Procedure

Intervention Name(s)

magnetic resonance imaging

Intervention Type

Procedure

Intervention Name(s)

sentinel lymph node biopsy

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Changes in MR T1 and T2 signal intensity

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen A. Kurdziel, MD

Organizational Affiliation

Massey Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Massey Cancer Center at Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0037

Country

United States

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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