Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00087347


Primary Contact:

Study Chair
Mukesh Harisinghani, MD
Massachusetts General Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

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