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


N/A
N/A
N/A
Not Enrolling
Male
Bladder Cancer, Genitourinary Cancer, Prostate Cancer

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sensitivity of MRI Per Patient

Outcome 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).

Outcome 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

Safety Issue:

Yes

Principal Investigator

Haesun Choi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2004-0003

NCT ID:

NCT00147238

Start Date:

July 2005

Completion Date:

January 2007

Related Keywords:

  • Bladder Cancer
  • Genitourinary Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Genitourinary Cancer
  • Prostate Cancer
  • MR Lymphangiography
  • Ferumoxtran-10
  • SPIO
  • Ultra-small superparamagnetic agent iron oxide
  • Urinary Bladder Neoplasms
  • Prostatic Neoplasms
  • Urogenital Neoplasms

Name

Location
U.T.M.D. Anderson Cancer Center Houston, Texas  77030