A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Bladder Cancer, Genitourinary Cancer, Prostate Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer, Genitourinary Cancer, Prostate Cancer, MR Lymphangiography, Ferumoxtran-10, SPIO, Ultra-small superparamagnetic agent iron oxide
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- U.T.M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ferumoxtran-10 MRI
MRI
MR lymphangiography using Ferumoxtran-10 contrast agent.
MR lymphangiography before injecting Ferumoxtran-10 contrast agent.