Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
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Purpose
The goal of our project is to establish a novel, non-invasive, immediately clinically applicable imaging test for the differentiation of bone sarcomas (osteosarcomas and Ewing sarcomas) and osteomyelitis.
| 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 |
- 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 2014 |
| Estimated Primary Completion Date: | March 2014 (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 |
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| Contact: Christopher Klenk | (650) 724-3191 | klenk@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Principal Investigator: Dr. Neyssa Marina | |
| 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: | May 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Osteosarcoma Bone Neoplasms Chondrosarcoma Osteomyelitis Rhabdomyosarcoma Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms by Site Neoplasms Bone Diseases Musculoskeletal Diseases Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Bone Diseases, Infectious Infection Myosarcoma Neoplasms, Muscle Tissue Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Ferumoxytol Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013