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Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

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ClinicalTrials.gov Identifier: NCT01336803
Recruitment Status : Recruiting
First Posted : April 18, 2011
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

Condition or disease Intervention/treatment Phase
Bone Cancer Chondrosarcoma Ewing's Sarcoma Osteosarcoma Rhabdomyosarcoma Bone Necrosis Bone Sarcoma Osteomyelitis Drug: Feraheme Procedure: MR Scan Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early postcontrast T1-weighted images.

II. Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.

III. Establish T2-weighted MR imaging characteristics of iron labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.

IV. Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam.

OUTLINE:

Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Study Start Date : August 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
Active Comparator: Control
MR imaging without Feraheme
 Procedure: MR Scan
Standard of Care
Other Name: GE 1.5T and 3T MRI scanners


Outcome Measures
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Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 1 year ]
  2. Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced MRI. [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
  • Symptomatic osteonecrosis (ON) of the femur or proximal tibia with MR signal abnormalities that involve more than 50% of the respective joint surface, but no evidence of epiphyseal collapse
  • 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:

  • Contraindication to MRI
  • Presence of metal implants
  • Need for sedation or anesthesia
  • Claustrophobia
  • Hemosiderosis/hemochromatosis (patients can still be included in the 2nd branch without receiving ferumoxytol)
  • There will be no restrictions regarding use of other investigational agents
  • Patients with evidence of iron overload, hemosiderosis/hemochromatosis will be excluded for the bone sarcoma study; however, they can undergo MRI exam without ferumoxytol enhancement for the ON study
  • 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336803


Contacts
Contact: Anne Muehe amuehe@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Principal Investigator: Heike Daldrup-Link         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Heike E Daldrup-Link, MD Stanford University
Principal Investigator: Neyssa Marina, MD Stanford University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01336803     History of Changes
Other Study ID Numbers: PEDSBONE0006
SU-04062011-7666 ( Other Identifier: Stanford University )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Osteosarcoma
Sarcoma
Necrosis
Rhabdomyosarcoma
Sarcoma, Ewing
Osteomyelitis
Chondrosarcoma
Bone Neoplasms
Osteonecrosis
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
 Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Site
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions