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

• 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: Heike E Daldrup-Link
• Information provided by (Responsible Party): Heike E Daldrup-Link, Stanford University

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Heike E Daldrup-Link

Investigators

• 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:

Study Protocol and Statistical Analysis Plan  [PDF] April 4, 2011

More 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
• 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

• 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:

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