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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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Prostate Cancer

Thank you

Trial Information

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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Mukesh Harisinghani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000374491

NCT ID:

NCT00087347

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Prostate Cancer
  • 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
  • Breast Neoplasms
  • Prostatic Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114