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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087347
• Other study ID #: CDR0000374491
• Secondary ID: MGH-2004-P-00068
• Status: Completed
• Phase: N/A
• First received: July 8, 2004
• Last updated: May 12, 2013
• Start date: September 2004

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior therapy for metastatic disease

Study Design

N/A

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ferumoxytol

Procedure:
• magnetic resonance imaging

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Harisinghani M, Ross RW, Guimaraes AR, Weissleder R. Utility of a new bolus-injectable nanoparticle for clinical cancer staging. Neoplasia. 2007 Dec;9(12):1160-5. — View Citation