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

NCT01815333 | Completed Results FDA Drug

• 2 other identifiers: 2012-0926NCI-2014-02435
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of Lymph Node

Keywords

Cancer of Lymph Node; Magnetic resonance imaging; MRI; Ultrasuperparamagnetic nanoparticle iron oxide; USPIO; Feraheme; Ferumoxytole

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Signal Intensity (SI) Change of a Lymph Node Between the Pre- and Post- Contrast of the Feraheme Enhanced Magnetic Resonance Imaging (MRI)

  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).

  3 days

Study Arms (1)

Feraheme

EXPERIMENTAL

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; Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Feraheme DRUG

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.

Also known as: Ferumoxytole

Feraheme

Magnetic Resonance Imaging (MRI) PROCEDURE

MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.

Feraheme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Primary or secondary iron overload
• Lactation or pregnant - women of child bearing potential will be excluded
• Contraindications for MRI
• Contraindication or allergy to Feraheme® (based on insert)
• 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
• Age under 18

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Haesun Choi, MD/ Professor, Abdominal Imaging Department
• Organization: UT MD Anderson Cancer Center

hchoi@mdanderson.org

713-745-4693

Study Officials

• Haesun Choi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: July 1, 2013
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-10

Locations

US (1)