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

July 31, 2012 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • U.T.M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas.
  2. Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks.
  3. Signed written consent and HIPAA authorization

Exclusion Criteria:

  1. Contraindications for MRI
  2. Claustrophobia, metals in the pelvis, previous pelvic surgery
  3. Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex
  4. 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
  5. Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.)
  6. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ferumoxtran-10 MRI
MR lymphangiography using Ferumoxtran-10 contrast agent.
Drug: Ferumoxtran-10 (USPIO)
Intravenous infusion of 2.6 mg/kg of ferumoxtran-10
Other Names:
  • MRI Contrast Agent
  • Ultra-small superparamagnetic oxide particles
Procedure: MR lymphangiography
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.
Other Names:
  • MRI
  • Magnetic Resonance Imaging
ACTIVE_COMPARATOR: MRI
MR lymphangiography before injecting Ferumoxtran-10 contrast agent.
Procedure: MR lymphangiography
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.
Other Names:
  • MRI
  • Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of MRI Per Patient
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Haesun Choi, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Ferumoxtran-10 (USPIO)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe