Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2017 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01336803
First received: April 12, 2011
Last updated: January 10, 2017
Last verified: January 2017
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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 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:
MedlinePlus related topics:
Soft Tissue Sarcoma
Drug Information available for:
Ferumoxytol
Genetic and Rare Diseases Information Center resources:
Soft Tissue Sarcoma
Osteosarcoma
Osteomyelitis
Ewing Sarcoma
Ewing's Family of Tumors
Chondrosarcoma
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- all cause mortality [ Time Frame: 1 year ]
- Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced MRI. [ Time Frame: 24 hours ]
| 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) |
| 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
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
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 ( Other Identifier: Stanford University ) |
| Study First Received: | April 12, 2011 |
| Last Updated: | January 10, 2017 |
Additional relevant MeSH terms:
|
Osteosarcoma Sarcoma Necrosis Rhabdomyosarcoma Sarcoma, Ewing Chondrosarcoma Osteomyelitis 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 |
ClinicalTrials.gov processed this record on May 25, 2017