N/A
Completed N=10
Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging
Cancer of Lymph Node
Source: ClinicalTrials.gov NCT01815333 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: 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) — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01815333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.