Trial Outcomes & Findings for Feraheme As An MRI Contrast Agent For Pediatric Congenital Heart Disease (NCT NCT02752191)
NCT ID: NCT02752191
Last Updated: 2022-12-28
Results Overview
1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
day 1
Results posted on
2022-12-28
Participant Flow
Participant milestones
| Measure |
Ferumoxytol
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
|
Gadofosveset
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
3
|
|
Overall Study
COMPLETED
|
14
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ferumoxytol
n=14 Participants
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
|
Gadofosveset
n=3 Participants
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants
|
3 Participants
n=3 Participants
|
17 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=14 Participants
|
1 Participants
n=3 Participants
|
7 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
3 participants
n=3 Participants
|
17 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: day 1Population: Includes all participants that had successfully reconstructed images
1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic
Outcome measures
| Measure |
Ferumoxytol
n=13 Participants
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
|
Gadofosveset
n=2 Participants
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
|
|---|---|---|
|
Composite Image Quality Score Among 7 Anatomical Structures.
|
3.9 score on a scale
Standard Deviation 0.1
|
2.7 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: day 1Population: includes participants with successfully reconstructed images.
1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic. 1. image quality score at the aortic root. 2. image quality score at the main pulmonary artery. 3. image quality score at the coronary arteries. 4. image quality score a the out-flow tracts. 5. image quality score at the valves. 6. image quality score at the ventricular chambers. 7. image quality at the atria.
Outcome measures
| Measure |
Ferumoxytol
n=13 Participants
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
|
Gadofosveset
n=2 Participants
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
|
|---|---|---|
|
Image Quality Score at Individual Anatomical Sites.
aortic root
|
3.8 score on a scale
Interval 3.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
|
Image Quality Score at Individual Anatomical Sites.
main pulmonary artery
|
3.9 score on a scale
Interval 3.0 to 4.0
|
3 score on a scale
Interval 3.0 to 3.0
|
|
Image Quality Score at Individual Anatomical Sites.
coronary arteries
|
3.8 score on a scale
Interval 3.0 to 4.0
|
2.5 score on a scale
Interval 2.0 to 3.0
|
|
Image Quality Score at Individual Anatomical Sites.
outflow tracts
|
4 score on a scale
Interval 4.0 to 4.0
|
2.5 score on a scale
Interval 2.5 to 2.5
|
|
Image Quality Score at Individual Anatomical Sites.
valves
|
4 score on a scale
Interval 4.0 to 4.0
|
2.5 score on a scale
Interval 2.5 to 2.5
|
|
Image Quality Score at Individual Anatomical Sites.
ventricular chambers
|
4 score on a scale
Interval 4.0 to 4.0
|
2.8 score on a scale
Interval 2.5 to 3.0
|
|
Image Quality Score at Individual Anatomical Sites.
atria
|
4 score on a scale
Interval 4.0 to 4.0
|
2.8 score on a scale
Interval 2.5 to 3.0
|
SECONDARY outcome
Timeframe: day 1Number of participants with one or more adverse events
Outcome measures
| Measure |
Ferumoxytol
n=14 Participants
Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes
ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes
|
Gadofosveset
n=3 Participants
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
|
|---|---|---|
|
Incidence of Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Ferumoxytol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gadofosveset
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place