Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01336803
First received: April 12, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

A research study on distinguishing between cancer and infection or inflammation using MRI and a new contrast agent (ferumoxytol). We hope to learn how to tell the difference between these two conditions with a simple MRI scan.


Condition Intervention
Bone Cancer
Chondrosarcoma
Ewing's Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Drug: Feraheme
Procedure: MR Scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced MRI. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Feraheme
Intravenous injection of Feraheme, 5 mg Fe/kg
Drug: Feraheme
5 mg Fe/kg iv
Other Name: ferumoxytol
Procedure: MR Scan
Standard of Care
Other Name: GE 1.5T and 3T MRI scanners

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria will comprise:

  • An age of 8-30 years
  • Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis.

The investigators do not include younger patients (age less than 8 yrs) in order to exclude need of sedation. There will be no gender/race-ethnic restrictions

In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate.

Exclusion Criteria:

Exclusion criteria will comprise:

  • Contraindication to MRI
  • Presence of metal implants
  • Need for sedation or anesthesia
  • Claustrophobia
  • Hemosiderosis/hemochromatosis

There will be no restrictions regarding use of other Investigational Agents.

Patients with evidence of iron overload, hemosiderosis/hemochromatosis will be excluded.

History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study.

Pregnancy or nursing patients will be excluded from the study. A pregnancy test will be done prior to the MR examination for postmenarchal teenage girls, in whom pregnancy may be possible. Only patients with a negative pregnancy test will be included in the study.

  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: NCT01336803

Contacts
Contact: Christopher Klenk (650) 724-3191 klenk@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Principal Investigator: Dr. Neyssa Marina         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Heike E Daldrup-Link Stanford University
Principal Investigator: Dr. Neyssa Maria Marina Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01336803     History of Changes
Other Study ID Numbers: PEDSBONE0006, SU-04062011-7666
Study First Received: April 12, 2011
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bone Diseases, Infectious
Bone Neoplasms
Osteosarcoma
Chondrosarcoma
Osteomyelitis
Rhabdomyosarcoma
Sarcoma, Ewing's
Sarcoma
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Infection
Myosarcoma
Neoplasms, Muscle Tissue
Ferumoxytol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014