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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

12 Years
Open (Enrolling)
Soft Tissue Sarcoma

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Trial Information

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
an electrocardiogram.

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.

Inclusion Criteria:

- New diagnosis of soft tissue sarcoma, who will undergo lymph node biopsy

- Able to tolerate MRI scan without sedation/anesthesia

- Greater than or equal to 12 years of age

Exclusion Criteria:

- Previous therapy other than biopsy or surgical resection of the primary tumor

- Pregnant or breastfeeding

- Receipt of other iron-oxide based nanoparticle therapy within 4 weeks of scans

- History of allergic reaction to compounds of similar composition to ferumoxytol

- Known diagnosis of hemochromatosis, mitochondrial disorder or iron overload

- Invasive bacterial infection

- Known history of contrast sensitivity

- Braces or metal heart valve that may interfere with MRI, surgical clips, a pacemaker,
piercings that cannot be removed, or any other indwelling metal device that might
interfere with MRI

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility and sensitivity of nanoparticle-enhanced MRI

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

Related Keywords:

  • Soft Tissue Sarcoma
  • Newly diagnosed
  • Sarcoma



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