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

• Status: Completed
• Trial end date: 2019-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Ferrosoferric Oxide

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