Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

NCT00980681

Renal Disease

TERMINATED PHASE3

Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

NCT01010932

Cerebral Arterial Diseases

COMPLETED PHASE3

DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases

NCT00955617

Peripheral Arterial Disease

COMPLETED PHASE4

Renal Artery Contrast-Free Trial

NCT01576835

Renal Artery Stenosis Kidney Diseases Hypertension

COMPLETED

Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

NCT00310557

Renal Artery Stenosis

COMPLETED PHASE3

Detailed Description

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

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Conditions

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

Renal Artery Stenosis

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dotarem

Each subject will receive one injection of Dotarem 0.2 ml/kg.

Group Type EXPERIMENTAL

Gadoterate meglumine (Dotarem)

Intervention Type DRUG

Each subject will receive one injection of Dotarem 0.2 ml/kg

Time Of Flight Magnetic Resonance Angiography

Each subject undergo a TOF MRA

Group Type OTHER

Time of Flight Magnetic Resonance Angiography

Intervention Type OTHER

Each subject will undergo a TOF MRA

Interventions

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

Gadoterate meglumine (Dotarem)

Each subject will receive one injection of Dotarem 0.2 ml/kg

Intervention Type DRUG

Time of Flight Magnetic Resonance Angiography

Each subject will undergo a TOF MRA

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Male or female, aged more than 18 years,
* Strongly suspected of having renal arterial disease,
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,

Exclusion Criteria

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²),
* Contraindication to MRI,
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No