Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT01853592
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gadofosveset Trisodium for Heart Imaging Studies
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)
Status:
COMPLETED
Status Verified Date:
2016-12-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
\- Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans.
Objectives:
\- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.
Eligibility:
\- Healthy volunteers between 18 and 45 years of age.
Design:
* Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions.
* Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study.
* Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan.
* An additional blood sample will be collected within 1 week of the second MRI scan.
\- Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans.
Objectives:
\- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.
Eligibility:
\- Healthy volunteers between 18 and 45 years of age.
Design:
* Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions.
* Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study.
* Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan.
* An additional blood sample will be collected within 1 week of the second MRI scan.
Detailed Description:
The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy participants will be recruited who do not have a clinical indication for MR angiography but do have safety clearance for IV gadolinium contrast and MR scanning.
Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.
Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 13-CC-0098 | None | None | View |