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

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


Study Type:	Observational
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer prostate cancer

MedlinePlus related topics: Diagnostic Imaging MRI Scans

Drug Information available for: Ferumoxytol

U.S. FDA Resources

Further study details as provided by Mukesh Harisinghani, MD, Massachusetts General Hospital:


Estimated Enrollment:	14
Study Start Date:	September 2004
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

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.


Responsible Party:	Mukesh Harisinghani, MD, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00087347 History of Changes
Other Study ID Numbers:	CDR0000374491 MGH-2004-P-000681/2 NCI-6809
Study First Received:	July 8, 2004
Last Updated:	May 12, 2013

Keywords provided by Mukesh Harisinghani, MD, Massachusetts General Hospital:


recurrent prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA 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

Additional relevant MeSH terms:


Breast Neoplasms Prostatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Neoplasms, Male	Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Ferrosoferric Oxide Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 18, 2017