USPIO Magnetic Resonance Imaging (MRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01815333
First received: March 19, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 2016 (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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01815333

Contacts
Contact: Haesun Choi, MD 713-745-4693

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
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: NCT01815333     History of Changes
Other Study ID Numbers: 2012-0926
Study First Received: March 19, 2013
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014