Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI (Osteosarcoma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336803
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Heike E Daldrup-Link, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Bone Cancer Chondrosarcoma Ewing's Sarcoma Osteosarcoma Rhabdomyosarcoma Bone Necrosis Bone Sarcoma Osteomyelitis Drug: Feraheme Procedure: Magnetic Resonance Imaging (MRI) scan Phase 2

Detailed Description:

BACKGROUND; In this study, T1, T2, and T2* represent parameters of magnetic resonance imaging (MRI).

The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).

T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 * is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2*). T2* is always ≤ T2. In this study, T2 * is assessed after 24 hours.

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.

PRIMARY OBJECTIVES:

  • Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.
  • Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
  • 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.
  • Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Actual Study Start Date : August 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Feraheme
Intravenous injection of Feraheme, 5 mg Fe/kg
Drug: Feraheme
5 mg/kg by intravenous (IV) administration
Other Name: ferumoxytol

Procedure: Magnetic Resonance Imaging (MRI) scan
Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Other Name: Magnetic Resonance (MR) scan




Primary Outcome Measures :
  1. T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects [ Time Frame: 24 hours ]
    Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 * relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 * values, with standard deviation.


Secondary Outcome Measures :
  1. Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast [ Time Frame: Baseline and Post-Treatment-24 hours ]
    Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 * relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.

  2. Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI [ Time Frame: 24 hours ]

    Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI.

    .


  3. Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas [ Time Frame: 24 hours ]
    Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.

  4. Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas [ Time Frame: 24 hours ]
    Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Age 10 to 21 years
  • Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
  • Informed consent with assent as appropriate.

EXCLUSION CRITERIA

  • Contraindication to MRI
  • Presence of metal implants
  • Need for sedation or anesthesia
  • Claustrophobia
  • Hemosiderosis or hemochromatosis
  • History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
  • Females who are pregnancy or nursing

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Heike E Daldrup-Link
Investigators
Layout table for investigator information
Principal Investigator: Heike E Daldrup-Link, MD Stanford University
Principal Investigator: Neyssa Marina, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Heike E Daldrup-Link, Stanford University:
Layout table for additonal information
Responsible Party: Heike E Daldrup-Link, Professor of Radiology (General Radiology), Stanford University
ClinicalTrials.gov Identifier: NCT01336803    
Other Study ID Numbers: IRB-20253(osteosarcoma)
SU-04062011-7666 ( Other Identifier: Stanford University )
PEDSBONE0006 ( Other Identifier: OnCore Number )
First Posted: April 18, 2011    Key Record Dates
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteomyelitis
Sarcoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma, Ewing
Chondrosarcoma
Bone Neoplasms
Osteonecrosis
Necrosis
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