Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00087347

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

Brief Summary

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) using ferumoxytol may improve the ability to detect cancer that has spread to the lymph nodes and may help plan effective cancer treatment.

PURPOSE: This clinical trial is studying how well MRI using ferumoxytol works in detecting metastases to the lymph nodes in patients with primary prostate cancer or primary breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Prostate Cancer	Drug: ferumoxytol Procedure: magnetic resonance imaging

Detailed Description

OBJECTIVES:

Primary

Determine the range of optimal timing for magnetic resonance imaging of lymph nodes after administration of ferumoxytol, in terms of assessing signal intensity using pre-defined pulse sequences in regions of interest and visual criteria, in patients with primary prostate or breast cancer who are scheduled to undergo surgical lymph node dissection or sampling.

Secondary

Correlate MRI signal intensity with histological findings in patients undergoing this procedure.

OUTLINE: This is an open-label, pilot study.

Patients undergo a baseline MRI. Within 24 hours after the baseline MRI, patients receive ferumoxytol IV over 10-15 seconds (or over 1 hour). Patients then undergo MRI immediately after ferumoxytol administration (at the discretion of the principal investigator) and then at 24-28 hours.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 10-14 patients (6-8 with prostate cancer and 4-6 with breast cancer) will be accrued for this study.

Study Design

Study Type:

Observational

Anticipated Enrollment :

14 participants

Official Title:

An NCI-Sponsored Exploratory Study For Determining Optimum Timing For The Imaging Of Intravenous Superparamagnetic Particle Ferumoxytol (Code7228) For The Differentiation of Metastatic and Non Metastatic Lymph Nodes in Patients With Known Primary Cancer Scheduled For Possible Surgical Lymph Node Biopsy/Dissection

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed primary prostate or breast cancer
Suspected lymph node metastatic disease by standard MRI or CT scan
Scheduled for surgical lymph node dissection or sampling
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Not specified

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

No prior ferritin > 800 ng/mL
No prior transferrin saturation > 60%
No history of iron overload or hemachromatosis
Patients with a clinical history of suspected iron overload or hemachromatosis must have normal serum iron, ferritin, and transferrin saturation

Hepatic

Bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT ≤ 2 times ULN

Renal

Not specified

Other

No requirement for monitored anesthesia during MRI
No known allergic or hypersensitivity reaction to any of the following parenterally-administered preparations:
Iron
Dextran
Iron dextran
Iron polysaccharide
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for at least 1 month before and during study participation