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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 20 May 2013
Main ID:  NCT00087347
Date of registration: 08/07/2004
Primary sponsor: Massachusetts General Hospital
Public title: Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer
Scientific 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
Date of first enrolment: September 2004
Target sample size: 14
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00087347
Study type:  Observational
Study design:  N/A  
Countries of recruitment
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Breast Cancer
Prostate Cancer
Intervention(s)
Drug: ferumoxytol
Procedure: magnetic resonance imaging
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
CDR0000374491
MGH-2004-P-000681/2
NCI-6809
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
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