Trial record 6 of 69 for:
Open Studies | "Bone Diseases, Infectious"
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Verified July 2014 by Stanford University
Information provided by (Responsible Party):
First received: April 12, 2011
Last updated: July 10, 2014
Last verified: July 2014
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.
Procedure: MR Scan
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
||Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2016 (Final data collection date for primary outcome measure)
Intravenous injection of Feraheme, 5 mg Fe/kg
5 mg Fe/kg iv
Other Name: ferumoxytol
Procedure: MR Scan
Standard of Care
Other Name: GE 1.5T and 3T MRI scanners
|Ages Eligible for Study:
||8 Years to 30 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 will comprise:
- Contraindication to MRI
- Presence of metal implants
- Need for sedation or anesthesia
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.
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
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
|Principal Investigator: Dr. Neyssa Marina |
||Dr. Heike E Daldrup-Link
||Dr. Neyssa Maria Marina
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 12, 2011
||July 10, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Bone Diseases, Infectious
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue