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Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: March 19, 2013
Last updated: May 13, 2016
Last verified: May 2016

The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole) helps researchers most clearly to "see" cancerous lymph nodes on an MRI scan. Researchers also want to learn if ferumoxytole may be used in liver imaging.

Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell counts) in patients with chronic kidney disease. In this study, it will be used as an MRI contrast. Contrasts are used by doctors in order to see MRI images more clearly.

Condition Intervention
Cancer of Lymph Node
Drug: Feraheme
Procedure: Magnetic Resonance Imaging (MRI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Feraheme Enhanced Magnetic Resonance Imaging (MRI) [ Time Frame: 3 days ]
    Signal intensity (SI) change of a lymph node between the pre- and post- contrast images observed subjectively at each time point. The degree of SI change at each time point compared each other subjectively and a time point showing the nodes best (greatest signal loss relative to that on pre-contrast images) identified (optimum scan time).

Estimated Enrollment: 18
Study Start Date: July 2013
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Feraheme
Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational.
Drug: Feraheme
6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.
Other Name: Ferumoxytole
Procedure: Magnetic Resonance Imaging (MRI)
MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.

Detailed Description:

Study Participation:

If you are found to be eligible, during the following MRI scans, you will pass into a long, narrow tube scanner, which is open at both ends. You will have a total of 3 MRI scans.

You will have an MRI scan before you receive ferumoxytole as needed. This is the standard-of-care MRI scan. You will then receive ferumoxytole by vein. If you are scheduled to have an MRI scan of your abdomen, or if you have visible lymph nodes in the abdomen, you will stay in the MRI scanner an extra 30 minutes for liver imaging right after you receive your dose of ferumoxytole. This is a part of an investigational scan (Visit 1--Day 1)

You will then return for an MRI scan 2 days later (Visit 2--Day 2) and then again the following day (Visit 3--Day 3) to scan your lymph nodes. These are the investigational scans. The timing of the second and third scans may be changed based on the study doctor's decision.

Length of Study:

Your participation on this study will be over after the third MRI scan.

Additional Information:

The images collected as part of this study will not be included as part of your medical record. If any of the images and/or information from this study are used for publication, all identifiable information will be removed. The data will be stored for 5 years after the study data has been published.

This is an investigational study. Ferumoxytole is FDA approved and commercially available for the treatment of iron-deficiency anemia in patients with chronic kidney disease. Its use to help researchers "see" cancerous lymph nodes from an MRI scan is considered investigational.

Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Enrolled at MDACC, Written consent
  2. Measurable nodes on the recent cross sectional imaging (CT, MRI. US) or suspicious lymph nodes for metastasis
  3. Requiring tissue diagnosis (FNA, core biopsy, surgical biopsy, surgical resection), or clinical follow-ups for at least 6 months.
  4. Any and all primary disease sites in the abdomen and pelvis will be allowed

Exclusion Criteria:

  1. Primary or secondary iron overload
  2. Lactation or pregnant - women of child bearing potential will be excluded
  3. Contraindications for MRI
  4. Contraindication or allergy to Feraheme® (based on insert)
  5. 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), anemia not caused by iron deficiency
  6. Age under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01815333

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Haesun Choi, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01815333     History of Changes
Other Study ID Numbers: 2012-0926
NCI-2014-02435 ( Registry Identifier: NCI CTRP )
Study First Received: March 19, 2013
Last Updated: May 13, 2016

Keywords provided by M.D. Anderson Cancer Center:
Cancer of Lymph Node
Magnetic resonance imaging
Ultrasuperparamagnetic nanoparticle iron oxide

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on April 28, 2017