Ferumoxytol-Enhanced Magnetic Resonance Imaging (MRI) in Pediatric and Adult Patients With Malignant Sarcoma: A Two-part Pilot Study for Safety and Efficacy in the Pediatric and Adult Populations
Before the research starts you will undergo some screening procedures to confirm that you
are eligible to participate in the study. These include a medical history, blood tests and
After we confirm taht you are eligible for this study you will undergo the following. We
estimate that you will be on the study for approximately two to three weeks.
Baseline MRI of the tumor site and draining lymph nodes: Whether you are on the study or not
you will have a baseline MRI which involves the use of a standard contrast agent called
gadolinium. This imaging test is considered the standard of care and is the method by which
doctors determine tumor location and spread. This MRI is NOT part of the study.
Ferumoxytol Infusion: You will receive this study drug the same day as your baseline MRI; if
you already had your baseline MRI, this medication can be given intravenously (i.e. directly
into the vein) at your next clinical visit. It can likewise be given through a central line.
You will be observed during the infusion and 30 minutes after the infusion to ensure that
you do not have an allergic or adverse reaction to the medication.
Repeat MRI of the tumor site and draining lymph nodes: Three to five days after receiving
ferumoxytol, you will undergo a repeat MRI. You will not require any additional contrast
prior to this imaging study. This MRI is part of the study.
Lymph Node Biopsy: You will be undergoing a lymph node biopsy whether or not you are on the
study. This will occur approximately a week after your study MRI. This is a surgical
procedure that involves removing one or a few lymph nodes in the region of your tumor and
studying them under a microscope to determine whether they contain signs of microscopic
cancer spread. Your surgeon will explain this procedure to you in more detail.
We anticipate that your clinic visit for ferumoxytol will take approximately an hour. MRI
tests, on average, likewise take approximately an hour to complete.
After you have completed the study MRI and lymph node biopsy, you will require one
additional blood test to measure blood iron levels. We measure iron levels because
ferumoxytol is comprised of an iron core. This iron is similar to that in oral iron
supplements and can cause your blood iron levels to temporarily increase. Because we are
trying to determine whether this contrast agent will be useful, you will not receive teh
results to the study MRI. If however, lymph nodes are found to be positive for disease, your
treatment plan may change to address this.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility and sensitivity of nanoparticle-enhanced MRI
To determine the feasibility and evaluate the sensitivity of using nanoparticle-enhanced MRI in detecting lymph node metastases in pediatric and adult soft tissue sarcoma patients with clinically palpable or radiographically concerning lymph nodes, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard
Carlos Rodriguez-Galindo, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Children's Hospital Boston||Boston, Massachusetts 02115|