Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

NCT01336803 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-20253(osteosarcoma)SU-04062011-7666PEDSBONE0006
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Cancer; Chondrosarcoma; Ewing's Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Bone Necrosis; Bone Sarcoma; Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast

  Baseline and Post-Treatment-24 hours

• Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI

  24 hours

• Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

  24 hours

• Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

  24 hours

Study Arms (1)

Feraheme

EXPERIMENTAL

Intravenous injection of Feraheme, 5 mg Fe/kg

Drug: Feraheme; Procedure: Magnetic Resonance Imaging (MRI) scan

Interventions

Feraheme DRUG

5 mg/kg by intravenous (IV) administration

Also known as: ferumoxytol

Feraheme

Magnetic Resonance Imaging (MRI) scan PROCEDURE

Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/

Also known as: Magnetic Resonance (MR) scan

Feraheme

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heike E Daldrup-Link: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bone Neoplasms; Chondrosarcoma; Sarcoma, Ewing; Osteosarcoma; Rhabdomyosarcoma; Osteonecrosis; Osteomyelitis

Interventions

Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Bone Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Infections

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Heike Daldrup-Link
• Organization: Stanford University

heiked@stanford.edu

650-723-8996

Study Officials

• Heike E Daldrup-Link, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Neyssa Marina, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology (General Radiology)

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 18, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: October 1, 2023
• Last Updated: December 27, 2023
• Results First Posted: June 18, 2019

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)