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Tracking Information | |||||
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First Received Date ICMJE | July 8, 2004 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date ICMJE | September 2004 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00087347 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Magnetic Resonance Imaging of Lymph Nodes Using Ferumoxytol in Patients With Primary Prostate or Breast Cancer | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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Detailed Description | 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. |
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Study Phase | |||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Diagnostic, Open Label | ||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | Harisinghani M, Ross RW, Guimaraes AR, Weissleder R. Utility of a new bolus-injectable nanoparticle for clinical cancer staging. Neoplasia. 2007 Dec;9(12):1160-5. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 14 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00087347 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | CDR0000374491, MGH-2004-P-000681/2, NCI-6809 | ||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | September 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |