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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00147238
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Genitourinary Cancer; Prostate Cancer	Drug: Ferumoxtran-10 (USPIO); Procedure: MR lymphangiography	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sensitivity of MRI Per Patient [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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. 1. 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UT MD Anderson Cancer Center website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00147238
• Other Study ID Numbers: 2004-0003
• First Posted: Sep 7, 2005
• Last Update Posted: Aug 7, 2012
• Last Verified: Jul 1, 2012

• 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: Prostatic Neoplasms; Urinary Bladder Neoplasms; Urogenital Neoplasms

Study Results

Participant Flow

Recruitment Details	Recruitment Period: 08/24/05 through 06/12/06. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Detail	A total of 10 patients enrolled prior to sponsor's request for early termination. Only 2 patients were evaluable for response therefore data will not be analyzed due to too small sample size.

Arm/Group Title	Ferumoxtran-10 MRI Contrast Agent
Arm/Group Description
Period Title: Overall Study
STARTED	10
COMPLETED	2
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Ferumoxtran-10 MRI Contrast Agent
Arm/Group Description
Overall Participants	10
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64
Sex: Female, Male (Count of Participants)
Female	8 80%
Male	2 20%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).

Arm/Group Title	Ferumoxtran-10 MRI Contrast Agent
Arm/Group Description
Measure Participants	0

Adverse Events

Time Frame	9 Months (September 2005-June 2006)
Arm/Group Title	Ferumoxtran-10 MRI Contrast Agent
Arm/Group Description
All Cause Mortality
	Ferumoxtran-10 MRI Contrast Agent
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ferumoxtran-10 MRI Contrast Agent
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Ferumoxtran-10 MRI Contrast Agent
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.