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Sponsors and Collaborators: |
Massachusetts General Hospital National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00087347 |
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.
Condition | Intervention |
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Breast Cancer Prostate Cancer |
Drug: ferumoxytol Procedure: magnetic resonance imaging |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | 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 |
Estimated Enrollment: | 14 |
Study Start Date: | September 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
No history of iron overload or hemachromatosis
Hepatic
Renal
Other
No known allergic or hypersensitivity reaction to any of the following parenterally-administered preparations:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 |
Study Chair: | Mukesh Harisinghani, MD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000374491, MGH-2004-P-000681/2, NCI-6809 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00087347 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage I prostate cancer stage II 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 |
Prostatic Diseases Genital Neoplasms, Male Skin Diseases Breast Neoplasms Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |