A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

Study Overview
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Brief Summary
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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 lymph nodes.

Detailed Description
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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. 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. A total of 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Official Title
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A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

Conditions
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Bladder Cancer, Genitourinary Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: Ferumoxtran-10 (USPIO)
* Procedure: MR lymphangiography


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferumoxtran-10 MRI<br>MR lymphangiography using Ferumoxtran-10 contrast agent. | Drug: Ferumoxtran-10 (USPIO)<br>* Intravenous infusion of 2.6 mg/kg of ferumoxtran-10<br>* Other names: Ultra-small superparamagnetic oxide particles;Procedure: MR lymphangiography<br>* First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.<br>* Other names: Magnetic Resonance Imaging;|
| Active Comparator: MRI<br>MR lymphangiography before injecting Ferumoxtran-10 contrast agent. | Procedure: MR lymphangiography<br>* First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.<br>* Other names: Magnetic Resonance Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of MRI Per Patient | Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high). | MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Cancer, Genitourinary Cancer, Prostate Cancer, MR Lymphangiography, Ferumoxtran-10, SPIO, Ultra-small superparamagnetic agent iron oxide