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Trial Outcomes & Findings for Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI (NCT NCT01336803)

NCT ID: NCT01336803

Last Updated: 2023-12-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

24 hours

Results posted on

2023-12-27

Participant Flow

Participant milestones

Participant milestones
Measure
Feraheme
Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg by intravenous adminstration MR Scan: Standard of Care
Overall Study
STARTED
21
Overall Study
Bone Sarcoma
10
Overall Study
Osteomyelitis
4
Overall Study
Lymphoma
7
Overall Study
COMPLETED
21
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Feraheme
n=21 Participants
Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg by intravenous adminstration MR Scan: Standard of Care
Age, Categorical
<=18 years
16 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
14.7 Years
STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Region of Enrollment
United States
21 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis.

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.

Outcome measures

Outcome measures
Measure
Bone Sarcomas
n=5 Participants
Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
Osteomyelitis
n=4 Participants
Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects
7.3 milliseconds
Standard Deviation 1.9
7.7 milliseconds
Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and Post-Treatment-24 hours

Population: Only the participants with bone sarcomas were evaluated for this outcome.

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.

Outcome measures

Outcome measures
Measure
Bone Sarcomas
n=10 Participants
Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
Osteomyelitis
Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
Pre-treatment
13.80 milliseconds
Standard Deviation 2.80
—
Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast
Post-treatment
8.27 milliseconds
Standard Deviation 2.12
—

SECONDARY outcome

Timeframe: 24 hours

Population: The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study.

Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \* relaxation time determined by ferumoxytol-enhanced MRI. .

Outcome measures

Outcome measures
Measure
Bone Sarcomas
n=7 Participants
Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
Osteomyelitis
n=10 Participants
Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI
14.83 milliseconds
Standard Deviation 1.03
7.71 milliseconds
Standard Deviation 0.60

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Bone Sarcomas
n=7 Participants
Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
Osteomyelitis
n=10 Participants
Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
4.8 Percentage of CD68-positive TAM
Standard Deviation 1.2
6.1 Percentage of CD68-positive TAM
Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Bone Sarcomas
n=7 Participants
Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.
Osteomyelitis
n=10 Participants
Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.
Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas
1.9 Percentage area of CD163-positive TAM
Standard Deviation 1.5
9.4 Percentage area of CD163-positive TAM
Standard Deviation 3.1

Adverse Events

Feraheme

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Feraheme
n=21 participants at risk
Intravenous injection of Feraheme, 5 mg Fe/kg Feraheme: 5 mg Fe/kg iv MR Scan: Standard of Care
Immune system disorders
Allergic reaction
4.8%
1/21 • Number of events 1 • 24 hours

Additional Information

Heike Daldrup-Link

Stanford University

Phone: 650-723-8996

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place