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Completed

NCT Number: NCT00395460

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

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Key information

Conditions

Central Nervous System Diseases Bone Diseases Musculoskeletal Diseases Nervous System Diseases Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jiangsu Province Hospital, Nanjing, Jiangsu, China

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About this study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese origin, with known or suspected brain or spine diseases

Exclusion criteria

  • Pregnancy
  • Lactation
  • Conditions interfering with MRI
  • Allergy to any contrast agent or any drugs
  • Participation in other trial
  • Require emergency treatment
  • Severely impaired liver and kidney functions

Treatment and study plan

Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Drug

1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW)

Magnevist

Drug

0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW)

Primary outcomes

  1. Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    CNR = (signal intensity [SI] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.

Secondary outcomes

  1. Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    The number of lesions in the magnetic resonance scans was recorded before and after injection of contrast agent for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).

  2. Change in Diagnostic Confidence From Pre- to Post-contrast Magnetic Resonance Imaging by Treatment

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    The change in diagnostic confidence was assessed based on post-contrast compared to pre-contrast scans as "improved", "unchanged" or "worsened" for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).

  3. Change in Lesion Contrast Enhancement From Pre- to Post-contrast MRI

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    The degree of contrast enhancement was recorded on a 4-point scale as follows: 1 = No: lesion is not enhanced. 2 = Moderate: lesion is weakly enhanced. 3 = Good: lesion is clearly enhanced. 4 = Excellent: lesion is clearly and brightly enhanced. In case of more than one lesion, the lesion with maximum enhancement was to be assessed. The change in lesion contrast enhancement was assessed based on post-contrast in comparison to pre-contrast scans for the investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).

  4. Change in Lesion Delineation Between Pre- and Post-contrast MRI Scan of CNS Lesions

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    Lesion delineation was recorded on a 4-point scale as follows: 1 = None: no or unclear delineation of the boundary between lesion and surrounding tissue; 2 = Moderate: some aspects of border delineation covered; 3 = Good: almost clear delineation, but not complete on relevant slices; 4 = Excellent: sharp and complete delineation. In case of more than one lesion, the lesion with maximum enhancement was assessed. Change in lesion delineation was assessed based on post-contrast in comparison to pre-contrast scans for investigators and all 3 blinded readers (reader 2, reader 3 and reader 4).

Other outcomes

  1. Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.

  2. Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    CNR = (SI lesion - SI normal tissue) / SD background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.

  3. Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of CNS Lesions in Participants With Malignant Brain Tumor(s) / Brain Metastases

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    Investigators and blinded readers (reader 2, 3 and 4) were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.

  4. Change in Number of Detected Lesions From Pre- to Post-contrast MRI Scan of Participants With CNS Lesions Other Than Primary Malignant Brain Tumor(s) / Brain Metastases

    Time frame: Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)

    Investigators and blinded readers (reader 2, 3 and 4= were to record the number of lesions in the magnetic resonance scans before and after injection of contrast agent.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 3, 2006
Registry last updated
Jun 8, 2015

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

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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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