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Trial Outcomes & Findings for Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI (NCT NCT02893293)

NCT ID: NCT02893293

Last Updated: 2024-11-26

Results Overview

SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise. First, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

week 1 postsurgery

Results posted on

2024-11-26

Participant Flow

Participant milestones

Participant milestones
Measure
Ferumoxytol-enhanced MRI
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Non-ferumoxytol Enhanced MRI
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Overall Study
STARTED
9
5
Overall Study
COMPLETED
8
5
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ferumoxytol-enhanced MRI
n=9 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Non-ferumoxytol Enhanced MRI
n=5 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Total
n=14 Participants
Total of all reporting groups
Age, Categorical
<=18 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
8 Participants
n=5 Participants
5 Participants
n=7 Participants
13 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=5 Participants
0 Participants
n=7 Participants
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
5 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
9 Participants
n=5 Participants
5 Participants
n=7 Participants
14 Participants
n=5 Participants

PRIMARY outcome

Timeframe: week 1 postsurgery

Population: Participants who completed the protocol

SNR is a measurement that compares the strength of a signal to the level of background noise. It is often expressed in decibels (dB) and is calculated by dividing the signal power by the noise power. A ratio greater than 1:1 indicates that there is more signal than noise. First, for each lesion the MR signal intensity (SI) of the lesion and the SI of the background (= noise in the image) was measured, then the SI of the lesion was divided by the SI of the noise to obtain the signal to noise ratio. Then, the mean SNR and standard deviation was calculated for the different groups of lesions and compared to the mean SNR between treated versus not treated lesions and treated lesions at different time points after the treatment using statistical tests.

Outcome measures

Outcome measures
Measure
Ferumoxytol-enhanced MRI
n=8 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Non-ferumoxytol Enhanced MRI
n=5 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Signal to Noise Ratio (SNR)
33.82 dB
Standard Deviation 12.43
129.56 dB
Standard Deviation 10.93

PRIMARY outcome

Timeframe: week 1 postsurgery

Population: Participants who completed the protocol

T2\* relaxation time is a measure of how quickly transverse magnetization decays in magnetic resonance imaging (MRI). It's a key factor in image contrast in gradient-echo (GRE) sequences and is used in many MRI applications, such as perfusion imaging, susceptibility-weighted imaging, and functional imaging. Lower T2\* relaxation times indicate greater contrast agent uptake in cells.

Outcome measures

Outcome measures
Measure
Ferumoxytol-enhanced MRI
n=8 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Non-ferumoxytol Enhanced MRI
n=5 Participants
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
T2*-Relaxation Time
9.04 milliseconds
Standard Deviation 0.7
13.7 milliseconds
Standard Deviation 2.50

PRIMARY outcome

Timeframe: one year

Population: Long-term follow up was conducted in the ferumoxytol group only

Number of femurs that did not collapse by 1 year follow up. Evaluation of progression of osteonecrosis via scale 1-4, bone marrow edema, collapse of subchondral fractures.

Outcome measures

Outcome measures
Measure
Ferumoxytol-enhanced MRI
n=16 Femur
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive ferumoxytol injection (Feraheme, AMAG, 5mg Fe/kg, single administration), and follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Non-ferumoxytol Enhanced MRI
Patients scheduled for routine decompression surgery and autologous stem cell transplant receive follow-up magnetic resonance imaging in regular intervals for evaluation of the response to treatment.
Evaluation of Treatment Response to Decompression Surgery and Stem Cell Transplant
12 Femur
—

Adverse Events

Ferumoxytol-enhanced MRI

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

Non-ferumoxytol Enhanced MRI

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heike Daldrup-Link, MD

Stanford University

Phone: (650) 725-2548

Results disclosure agreements

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