Clinical trial

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

Name

IRB-20253(osteosarcoma)

Description

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.

Trial arms

Trial start

2011-08-01

Estimated PCD

2014-07-01

Trial end

2023-10-01

Status

Completed

Phase

Early phase I

Treatment

Feraheme

5 mg/kg by intravenous (IV) administration

Arms:

Feraheme

Other names:

ferumoxytol

Magnetic Resonance Imaging (MRI) scan

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

Arms:

Feraheme

Other names:

Magnetic Resonance (MR) scan

Size

Primary endpoint

T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects

24 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2023-12-27

1 organization

1 product

8 indications

Organization

Heike E Daldrup-Link

Product

Feraheme

Indication

bone cancer

Indication