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NCT00459446 · ClinicalTrials.gov registry record · Phase 1

Imaging of Totally Blocked Arteries

A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT00459446: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

NCT00459446 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00459446, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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

Interventions

  • DRUG MS-325 Injection (Gadofosveset Trisodium)

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-04-05
Phase Phase 1

What the finished NCT00459446 record still lists

NCT00459446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which MS-325 Injection (Gadofosveset Trisodium) is the first listed.

NCT00459446 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00459446 about?

NCT00459446 is a clinical study titled "Imaging of Totally Blocked Arteries". 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 som...

What is the current status of trial NCT00459446?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-04-05.

What interventions are being tested in trial NCT00459446?

The interventions under investigation include: MS-325 Injection (Gadofosveset Trisodium) (DRUG).

Who is sponsoring clinical trial NCT00459446?

This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00459446's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00459446, the US trial registry maintained by the National Library of Medicine. NCT00459446 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.