Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
Carlos Ridriguez-Galindo, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01663090
First received: July 28, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

This research study is a pilot study to evaluate a new contrast agent, ferumoxytol, for the purpose of imaging lymph node metastases in patients with soft tissue sarcoma. This contrast agent is an investigational drug. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved ferumoxytol for this use. This drug has been used to image adults with other forms of cancer, however, it has only been used to image a small number of pediatric patients. Ferumoxytol has never been used to image sarcoma.


Condition Intervention
Soft Tissue Sarcoma
Drug: Ferumoxytol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility and sensitivity of nanoparticle-enhanced MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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

  • Sensitivity of nanoparticle-enhanced MRI in occult lymph node metastases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the sensitivity of nanoparticle-enhanced MRI in detecting occult lymph node metastases in pediatric and adult patients with soft tissue sarcoma, whereby the minimum acceptable sensitivity was selected based on a histologic gold standard


Secondary Outcome Measures:
  • Safety of ferumoxytol in pediatric patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The safety of ferumoxytol in pediatric patients will be assessed by the proportion of patients who experience at least one dose limiting toxicity (DLT). DLT refers to toxicities experienced after the start of the drug infusion; they are based on the Common Terminology Criteria for Adverse Events version 4.0.

  • Sensitivity of conventional MRI vs. nanoparticle enhanced MRI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the sensitivity of conventional MRI in detecting the presence of lymph node abnormalities in pediatric and adult patients with soft tissue sarcoma, and to compare this to the sensitivity of nanoparticle-enhanced MRI. The sensitivity of nanoparticle-enhanced MRI will be descriptively compared to the sensitivity of conventional MRI, where in each case the histological confirmation of lymph node involvement is the "standard of truth." For conventional MRI, sensitivity will be measured by the number of patients in whom at least one lymph node abnormality was detected by conventional MRI, as determined by the primary radiologist, divided by the total number of evaluable patients.

  • Compare inter-reader variability in the interpretation of nanoparticle MRI scans [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine inter-reader variability in the interpretation of nanoparticle MRI scans by two independent radiologists. The comparison will be made between each central review radiologist's assessment of whether or not a given patient has a positive lymph node.

  • Retrospective central pathology review [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To perform a retrospective central pathology review to determine inter-pathologist interpretation of positive lymph nodes. This too will be done through comparison of each central review pathologist's assessment of whether or not a given patient has a positive lymph node.


Estimated Enrollment: 49
Study Start Date: September 2012
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nanoparticle enhanced MRI Drug: Ferumoxytol

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663090

Contacts
Contact: Carlos Rodriguez-Galindo, MD 6176324580 crodriguez-galindo@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: James Butrynski, MD    617-632-5204    jbutrynski@partners.org   
Principal Investigator: James Butrynski, MD         
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo, MD    617-632-4580    crodriguez-galindo@partners.org   
Principal Investigator: Carlos Rodriguez-Galindo, MD         
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo, MD    617-632-4580    crodriguez-galindo@partners.org   
Principal Investigator: Carlos Rodriguez-Galindo, MD         
Principal Investigator: James Butrynski, MD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Mukesh Harisinghani, MD    617-746-8396    mharisinghani@partners.org   
Principal Investigator: Mukesh Harisinghani, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Carlos Rodriguez-Galindo, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Carlos Ridriguez-Galindo, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01663090     History of Changes
Other Study ID Numbers: 11-254
Study First Received: July 28, 2012
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Newly diagnosed

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014