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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: ferumoxytol
* Procedure: magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ferumoxytol|nan|
|Procedure: magnetic resonance imaging|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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