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

Sponsors and Collaborators:	Massachusetts General Hospital National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00087347

Purpose

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	Intervention
Breast Cancer Prostate Cancer	Drug: ferumoxytol Procedure: magnetic resonance imaging

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer MRI Scans Prostate Cancer

Drug Information available for: Ferumoxytol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	14
Study Start Date:	September 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087347

Locations

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:

Mukesh Harisinghani, MD

Massachusetts General Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Study ID Numbers:	CDR0000374491, MGH-2004-P-000681/2, NCI-6809
Study First Received:	July 8, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00087347
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
stage I breast cancer

stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Breast Neoplasms
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009