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Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01336803
First received: April 12, 2011
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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 Intervention
Bone Cancer
Chondrosarcoma
Ewing's Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Bone Necrosis
Bone Sarcoma
Osteomyelitis
Drug: Feraheme
Procedure: MR Scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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
Active Comparator: Control
MR imaging without Feraheme
Procedure: MR Scan
Standard of Care
Other Name: GE 1.5T and 3T MRI scanners

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.

  Eligibility

Ages Eligible for Study:   8 Years to 40 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
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: 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

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: May 23, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 28, 2016