A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a clinical study of gadoteric acid in non-coronary MR angiography.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Occlusive Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gadoteric acid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female, at least the age of legal maturity
* Strongly suspected of having non-coronary arterial disease, detected clinically
* Scheduled to undergo x-ray angiography examination
* Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
* Females of childbearing potential must have a documented negative urine pregnancy test.

Exclusion Criteria

* Contraindication to magnetic resonance imaging (MRI)
* Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
* Congenital morphologic vascular abnormalities
* Known allergy to gadolinium chelates
* Pregnant, breast feeding, or planning to become pregnant during the trial
* Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Corinne Dubourdieu, PhD

Role: STUDY_CHAIR

Guerbet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DGD-44-042

Identifier Type: -

Identifier Source: org_study_id