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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ferrosoferric Oxide

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