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

Primary Purpose

Bladder Cancer, Genitourinary Cancer, Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ferumoxtran-10 (USPIO)
MR lymphangiography
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Ferumoxtran-10 MRI

MRI

Arm Description

MR lymphangiography using Ferumoxtran-10 contrast agent.

MR lymphangiography before injecting Ferumoxtran-10 contrast agent.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
July 31, 2012
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00147238
Brief Title
A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Official Title
A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated at request of sponsor.
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 lymph nodes.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Genitourinary Cancer, Prostate Cancer
Keywords
Bladder Cancer, Genitourinary Cancer, Prostate Cancer, MR Lymphangiography, Ferumoxtran-10, SPIO, Ultra-small superparamagnetic agent iron oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferumoxtran-10 MRI
Arm Type
Experimental
Arm Description
MR lymphangiography using Ferumoxtran-10 contrast agent.
Arm Title
MRI
Arm Type
Active Comparator
Arm Description
MR lymphangiography before injecting Ferumoxtran-10 contrast agent.
Intervention Type
Drug
Intervention Name(s)
Ferumoxtran-10 (USPIO)
Other Intervention Name(s)
MRI Contrast Agent, Ultra-small superparamagnetic oxide particles
Intervention Description
Intravenous infusion of 2.6 mg/kg of ferumoxtran-10
Intervention Type
Procedure
Intervention Name(s)
MR lymphangiography
Other Intervention Name(s)
MRI, Magnetic Resonance Imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of MRI Per Patient
Description
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).
Time Frame
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haesun Choi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.T.M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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