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

This study has been terminated.
(Terminated at request of sponsor.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00147238
First received: September 6, 2005
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Bladder Cancer
Genitourinary Cancer
Prostate Cancer
Drug: Ferumoxtran-10 (USPIO)
Procedure: MR lymphangiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 10
Study Start Date: July 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147238

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00147238     History of Changes
Other Study ID Numbers: 2004-0003
Study First Received: September 6, 2005
Results First Received: April 24, 2009
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Bladder Cancer
Genitourinary Cancer
Prostate Cancer
MR Lymphangiography
Ferumoxtran-10
SPIO
Ultra-small superparamagnetic agent iron oxide

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Prostatic Neoplasms
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014