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

Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

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.

Study Overview

• Status: Completed
• Conditions: Bone Cancer; Osteosarcoma; Chondrosarcoma; Rhabdomyosarcoma; Bone Sarcoma; Osteomyelitis; Bone Necrosis; Ewing's Sarcoma
• Intervention / Treatment: Drug: Feraheme; Procedure: Magnetic Resonance Imaging (MRI) scan

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feraheme; Intravenous injection of Feraheme, 5 mg Fe/kg	Drug: Feraheme; 5 mg/kg by intravenous (IV) administration; Other Names: ferumoxytol; Procedure: Magnetic Resonance Imaging (MRI) scan; Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/; Other Names: Magnetic Resonance (MR) scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Post-Treatment-24 hours
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. .	24 hours
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.	24 hours
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.	24 hours

Collaborators and Investigators

• Sponsor: Heike E Daldrup-Link
• Investigators: Principal Investigator: Heike E Daldrup-Link, MD, Stanford University; Principal Investigator: Neyssa Marina, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: April 12, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimated): April 18, 2011

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Bone Diseases, Infectious; Myosarcoma; Sarcoma; Bone Neoplasms; Necrosis; Sarcoma, Ewing; Osteosarcoma; Rhabdomyosarcoma; Chondrosarcoma; Osteonecrosis; Osteomyelitis; Hematinics; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Ferrosoferric Oxide
• Other Study ID Numbers: IRB-20253(osteosarcoma); PEDSBONE0006 (Other Identifier: OnCore Number); SU-04062011-7666 (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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