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The standard clinical cardiovascular MRI practice for children with CHD frequently involves the use of gadolinium-based contrast agents (GBCA) to enhance tissue contrast. Most GBCAs are small molecules that quickly cross the capillary wall and access the interstitial space, a process which diminishes the signal contrast between blood vessels and surrounding tissue. Therefore, these types of GBCA are most useful for first-pass MR angiography, wherein the images are acquired quickly during the initial 15-30 seconds post-injection when the GBCA concentration is much higher in the arteries than in the interstitial space. For young children with complex CHD, the stringent requirements for high spatial resolution, and the need for cardiac gating and good blood-myocardium contrast in order to provide detailed evaluation of intracardiac structures are not compatible with conventional GBCA-based first-pass MR angiography. Even with Ablavar® (gadofosveset trisodium), an FDA approved GBCA with longer intravascular half-life than other GBCAs, cardiac-gated Ablavar®-enhanced MRI may be insufficient for young children with CHD based on our institutional experience and on data from the literature; there remains diminished blood-tissue contrast during the high-resolution cardiac-gated MRI. Furthermore, there have been safety concerns regarding gadolinium deposition in brain tissues after repeated GBCA exposure as well as concerns of nephrogenic systemic fibrosis (NSF) associated with GBCA injection in young children < 2 years old who may have immature renal function. The long-term health consequences of these effects in the pediatric population are unclear. For the above reasons, we seek to study the diagnostic imaging effectiveness of Feraheme (Feraheme®), an FDA-approved drug for parenteral iron supplementation, as an MRI contrast agent in children with CHD. Although Feraheme® has been approved for the treatment of iron deficiency anemia secondary to renal disease, Feraheme® has been used as an off-label MRI contrast agent at select medical centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Active Comparator | Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes |
|
| gadofosveset | Active Comparator | gadofosveset, 0.03mmol/kg, one time bolus injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferumoxytol | Drug | ferumoxytol as an MRI contrast agent infused over several minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Image Quality Score Among 7 Anatomical Structures. | 1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality Score at Individual Anatomical Sites. | 1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol | Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes |
| FG001 | Gadofosveset | gadofosveset, 0.03mmol/kg, one time bolus injection gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol | Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes |
| BG001 | Gadofosveset |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Image Quality Score Among 7 Anatomical Structures. | 1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic | Includes all participants that had successfully reconstructed images | Posted | Mean | Standard Deviation | score on a scale | day 1 |
|
Duration of MRI exams, typically 1-2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferumoxytol | Ferumoxytol, 4mg/kg of body weight, one time infusion of several minutes ferumoxytol: ferumoxytol as an MRI contrast agent infused over several minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Paul Finn | UCLA | (310) 825-5344 | ohrpp@research.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2016 | Nov 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| C109932 | gadofosveset trisodium |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| gadofosveset | Drug | gadofosveset as an MRI contrast agent injected over several seconds |
|
|
| day 1 |
| Incidence of Adverse Events | Number of participants with one or more adverse events | day 1 |
gadofosveset, 0.03mmol/kg, one time bolus injection
gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Image Quality Score at Individual Anatomical Sites. | 1-4 image quality Likert score by an imaging expert, with 4 representing excellent image quality and 1 is non-diagnostic.
| includes participants with successfully reconstructed images. | Posted | Mean | Full Range | score on a scale | day 1 |
|
|
|
| Secondary | Incidence of Adverse Events | Number of participants with one or more adverse events | Posted | Count of Participants | Participants | day 1 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Gadofosveset | gadofosveset, 0.03mmol/kg, one time bolus injection gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds | 0 | 3 | 0 | 3 | 0 | 3 |
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| D008903 |
| Minerals |
| coronary arteries |
|
| outflow tracts |
|
| valves |
|
| ventricular chambers |
|
| atria |
|