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Completed

NCT Number: NCT01660841

Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

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Key information

Conditions

Magnetic Resonance Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects referred for a contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system based on current clinical symptoms or results of a previous imaging procedure

Exclusion criteria

  • Subjects with any contraindication to the MRI examination
  • Subjects with severe renal disease to end stage renal disease
  • Subjects scheduled or are likely to require a biopsy or any interventional therapeutic procedure within 72 (±4) hours after the study MRI

Treatment and study plan

Gadobutrol (Gadovist, BAY86-4875)

Drug

A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.

Primary outcomes

  1. Scores for visualization parameter: degree of contrast enhancement

    Time frame: Day of gadobutrol injection (Day 0)

    Blinded readers evaluate contrast of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

  2. Scores for visualization parameter: border delineation

    Time frame: Day of gadobutrol injection (Day 0)

    Blinded readers evaluate border delineation of at maximum 5 lesions and 4 normal brain structures in scans taken with and without injection of gadobutrol on a 4-point-scale.

  3. Scores for visualization parameter: internal morphology

    Time frame: Day of gadobutrol injection (Day 0)

    Blinded readers evaluate internal morphology of at maximum 5 lesions and 4 normal structures in scans taken with and without gadobutrol on a 3-point-scale.

  4. Number of detected lesions

    Time frame: Day of gadobutrol injection (Day 0)

    Blinded readers determine number of detected lesions in scans with and without gadobutrol.

Secondary outcomes

  1. Percentage of exact match of the MRI diagnosis with the final clinical diagnosis

    Time frame: Day of gadobutrol injection (Day 0)

    An exact match is defined as identical diagnosis given by the blinded reader and the independent standard of truth committee.

  2. Sensitivity and specificity to detect abnormal/normal brain tissue

    Time frame: Day of gadobutrol injection (Day 0)

    Blinded readers classify the brain tissue as normal or abnormal based on the MRI sets.

  3. Sensitivity and specificity to detect malignant Central Nervous System(CNS) lesions

    Time frame: Day of gadobutrol injection (Day 0)

    Percentage to correctly detect presence and absence of malignant lesions which are derived from the MR diagnosis of readers when compared with the diagnosis of the independent standard of truth committee.

  4. Number of participants with treatment emergent adverse events as a measure of safety and tolerability

    Time frame: 3 days after injection (Day 3)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2012
Registry last updated
Oct 1, 2014

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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