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
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.
Observational
N/A
Mukesh Harisinghani, MD
Study Chair
Massachusetts General Hospital
United States: Federal Government
CDR0000374491
NCT00087347
September 2004
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |