Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging
18 Years
N/A
Both
Cancer of the Lymph Nodes
Trial Information
Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging
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.
Inclusion Criteria:
1. Enrolled at MDACC, Written consent
2. Measurable nodes on the recent cross sectional imaging (CT, MRI. US) or ssuspicious
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Feraheme Enhanced Magnetic Resonance Imaging (MRI)
Outcome Description:
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).
Outcome Time Frame:
3 days
Safety Issue:
No
Principal Investigator
Haesun Choi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2012-0926
NCT ID:
NCT01815333
Start Date:
September 2013
Completion Date:
Related Keywords:
- Cancer of the Lymph Nodes
- Cancer of the lymph nodes
- Magnetic resonance imaging
- MRI
- Ultrasuperparamagnetic nanoparticle iron oxide
- USPIO
- Feraheme
- Ferumoxytole
Name | Location |
|---|---|
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
