Status:

COMPLETED

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

Lead Sponsor:

M.D. Anderson Cancer Center

Conditions:

Cancer of Lymph Node

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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....

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 25 2019

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT01815333

Start Date

July 1 2013

End Date

July 25 2019

Last Update

October 19 2020

Active Locations (1)

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1

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030