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

Primary Purpose

Bone Cancer, Chondrosarcoma, Ewing's Sarcoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Feraheme
Magnetic Resonance Imaging (MRI) scan
Sponsored by
Heike E Daldrup-Link
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Cancer

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feraheme

Arm Description

Intravenous injection of Feraheme, 5 mg Fe/kg

Outcomes

Primary Outcome Measures

T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects
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

Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
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.
Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI
Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI. .
Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
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.
Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
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.

Full Information

First Posted
April 12, 2011
Last Updated
November 21, 2022
Sponsor
Heike E Daldrup-Link
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1. Study Identification

Unique Protocol Identification Number
NCT01336803
Brief Title
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Acronym
Osteosarcoma
Official Title
Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2011 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heike E Daldrup-Link

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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. These patients will server as controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer, Chondrosarcoma, Ewing's Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Bone Necrosis, Bone Sarcoma, Osteomyelitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feraheme
Arm Type
Experimental
Arm Description
Intravenous injection of Feraheme, 5 mg Fe/kg
Intervention Type
Drug
Intervention Name(s)
Feraheme
Other Intervention Name(s)
ferumoxytol
Intervention Description
5 mg/kg by intravenous (IV) administration
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI) scan
Other Intervention Name(s)
Magnetic Resonance (MR) scan
Intervention Description
Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
Primary Outcome Measure Information:
Title
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
Description
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.
Time Frame
Baseline and Post-Treatment-24 hours
Title
Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI
Description
Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI. .
Time Frame
24 hours
Title
Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Description
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.
Time Frame
24 hours
Title
Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike E Daldrup-Link, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neyssa Marina, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

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