Clinical Trials Directory

Trials / Completed

CompletedNCT01336803

Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Heike E Daldrup-Link · Academic / Other
Sex
All
Age
10 Years – 21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFeraheme5 mg/kg by intravenous (IV) administration
PROCEDUREMagnetic Resonance Imaging (MRI) scanStandard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/

Timeline

Start date
2011-08-01
Primary completion
2014-07-01
Completion
2023-10-01
First posted
2011-04-18
Last updated
2023-12-27
Results posted
2019-06-18

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01336803. Inclusion in this directory is not an endorsement.