CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
MS-325 Injection (Gadofosveset Trisodium)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00459446
NCT00459446Phase 1Completed

Gadofosveset Imaging of Chronic Total Peripheral Artery Occlusion (CTO)

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Apr 12, 2007·Updated Jul 2, 2017

In Brief

A Phase 1 clinical trial evaluating MS-325 Injection (Gadofosveset Trisodium) for Atherosclerosis and 3 related conditions. Completed, across 1 site.

Detailed Summary

This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have some blood flowing through them), but only poorly in totally blocked arteries. This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in MRI scans, but is still considered experimental in the United States. People 18 years of age or older with known or suspected total blockage of an artery to the neck, arm or leg may be eligible for this study. Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours, during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works. Subjects may be asked to undergo a second scan using conventional MRI contrast dye

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2007
Enrollment StartApr 5, 2007
Primary CompletionNov 25, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.2 years ago

Interventions

MS-325 Injection (Gadofosveset Trisodium)drug