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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00147238 |
Primary Objective:
1. To re-validate the accuracy of ferumoxtran-10, a new ultra-small superparamagnetic oxide (USPIO) particles, using currently available a high-resolution MR imaging technique in patients with surgically resectable carcinomas of prostate, penis, and urinary bladder in their initial staging work-ups.
Condition | Intervention |
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Bladder Cancer Genitourinary Cancer Prostate Cancer |
Drug: Ferumoxtran-10 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast |
Estimated Enrollment: | 80 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | January 2007 |
The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles. Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. It takes about 24 - 36 hours to reach peak uptake in the lymph nodes. The ability of current imaging techniques to detect the lymph nodes disease is known to be less than perfect. Current techniques only use anatomic information (size). Previous studies have shown that this new contrast agent may be able to detect normal and abnormal lymph nodes, using MRI procedure, called MRI lymphangiogram. This new contrast agent is being evaluated to determine whether it can be used to detect normal and abnormal lymph nodes.
The study includes 2 parts. The first part will involve you receiving a MRI examination before the contrast is injected. The second part will involve you receiving a MRI examination about 24 hours after the injection. It will take about 20 minutes for each part.
If you are already scheduled to have a routine pelvic MRI, the first part of this study will be added at the end of the routine MRI. You will then be asked to return next day to complete the second part of the MRI. If you are not already scheduled to receive a MRI as part of your standard of care, you will come in to the MRI suite at M. D. Anderson and complete both parts over about a 24-hour interval.
You will be lying on the MRI examination table during the scanning. At the end of the first part of the study, the contrast will be infused slowly through vein over about 30 minutes in the recovery area. You will then be observed for 30 minutes to 2 hours, depending on your tolerance to the contrast agent. The images taken during the first part will be then be repeated 24-36 hours later. You will receive a follow-up telephone call from a member of the study staff on Day 3.
Once the second part of the MRI is performed, your participation in this study will be over.
This is an investigational study. This contrast agent is currently being evaluated by FDA and has not been approved yet. You will be charged for your routine MRI but not for the study MRIs. A total of 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Haesun Choi, MD | U.T.M.D. Anderson Cancer Center |
Study ID Numbers: | 2004-0003 |
Study First Received: | September 6, 2005 |
Last Updated: | March 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00147238 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Bladder Cancer Genitourinary Cancer Prostate Cancer |
MR Lymphangiography Ferumoxtran-10 SPIO |
Cystocele Prostatic Diseases Genital Neoplasms, Male Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Genital Diseases, Male Urologic Neoplasms Prostatic Neoplasms Urinary tract neoplasm Bladder neoplasm |
Neoplasms Neoplasms by Site |