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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• 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: Interventional
• Study design: Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Mukesh Harisinghani, MD
• Affiliation: Massachusetts General Hospital

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

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)