Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI - Full Text View

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:

Genetics Home Reference related topics: Ewing sarcoma

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Ferumoxytol

Genetic and Rare Diseases Information Center resources: Bone Cancer Malignant Mesenchymal Tumor Soft Tissue Sarcoma Ewing Sarcoma Ewing's Family of Tumors Osteomyelitis Osteosarcoma Chondrosarcoma

U.S. FDA Resources

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:


Sarcoma Necrosis Rhabdomyosarcoma Osteosarcoma Sarcoma, Ewing Chondrosarcoma Osteomyelitis Bone Neoplasms Osteonecrosis Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Pathologic Processes	Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Bone Tissue Neoplasms, Connective 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 September 26, 2016