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Completed

NCT Number: NCT00955617

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

This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guerbet

Roissy CDG, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male, aged ≥ 18 years
  • Patient suffering from Peripheral Arterial Occlusive Disease (PAOD) stage II or III.

Exclusion criteria

  • Patients with severely impaired renal function with an eGFR (MDRD) < 50ml/min (eGFR based on recent serum creatinine and MDRD formula - younger than 21 days).
  • Patient planned to undergo therapeutic intervention in the vessels of interest between the two MRA procedures.
  • Patient who had a major cardiovascular event within 30 days prior to the inclusion.

Treatment and study plan

Contrast-enhanced MRA - Imaging examination

Other

Administration of 0.1 mmol/kg of contrast product (Dotarem and Gadovist)

Other names: Dotarem-enhanced MRA, Gadovist-enhanced MRA

Primary outcomes

  1. Overall Image Quality of MRA Images

    Time frame: MRA examination

    Number of images quoted with excellent and more than adequate quality in each group.

    Image quality will be assessed on a 5-point scale:

    • Excellent
    • More than adequate
    • Adequate
    • Less than adequate
    • Non-diagnostic

    Each image is analysed by 4 readers.

Secondary outcomes

  1. Diagnostic Confidence

    Time frame: MRA examination

    Number of High/Excellent diagnostic confidence. Level of diagnostic confidence assessed on a 5-point scale by patient: nil, poor, moderate, high, excellent.

    Each image is analysed by 4 readers.

  2. Signal Intensity

    Time frame: MRA examination

    Signal to Noise ratio (SNR): SNR = SIa /NO SIa is the signal intensity measured in the ROI positioned in the artery. NO is noise defined as the standard deviation (SD) of signal intensity measured in the subtraction image (of the two non-enhanced scans) at the same location as the arterial ROI is to be measured.

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Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

Intra-individual Efficacy Evaluation of DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Lower Limb Arterial Diseases

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2009
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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