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
|
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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 |
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 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 |

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

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

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
Contact: Anne Muehe | amuehe@stanford.edu |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Principal Investigator: Heike Daldrup-Link |
Principal Investigator: | Heike E Daldrup-Link, MD | Stanford University | |
Principal Investigator: | Neyssa Marina, MD | Stanford University |
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 |