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

May 12, 2013 updated by: Mukesh Harisinghani, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Mukesh Harisinghani, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1593/neo.07940.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 8, 2004

First Submitted That Met QC Criteria

July 9, 2004

First Posted (Estimate)

July 12, 2004

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 12, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000374491
MGH-2004-P-000681/2
NCI-6809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.