Status:
TERMINATED
A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Bladder Cancer
Genitourinary Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic ...
Detailed Description
The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles (USPIO). Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. I...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas.
- Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks.
- Signed written consent and HIPAA authorization
Exclusion
- Contraindications for MRI
- Claustrophobia, metals in the pelvis, previous pelvic surgery
- Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex
- a. Prostate cancer: metastases demonstrated on preoperative imaging; prior hormonal therapy greater than 3 months; prior local therapy for prostate cancer b. Penile Cancer: prior systemic therapy for penile cancer; prior inguinal radiation c. Bladder Cancer: prior systemic therapy for bladder cancer (does NOT include intravesical chemotherapy or immunotherapy); prior pelvic radiation; history of partial cystectomy or prior pelvic lymph node dissection
- Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.)
- Clinically documented or risk of primary or secondary iron overloading (e.g.History of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple transfusions with any reason)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00147238
Start Date
July 1 2005
End Date
January 1 2007
Last Update
August 7 2012
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030