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

NCT00395460 | Completed Phase 3 Results

• 3 other identifiers: 91536Project DE 00562309761
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Central Nervous System Diseases

Keywords

Gadovist; Gadavist; Contrast agent; Brain; Spine disease; Magnetic Resonance Imaging

Outcome Measures

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

  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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Other Outcomes (4)

• 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

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

• 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

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

• 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

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

Study Arms (2)

Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)

EXPERIMENTAL

Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)

Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)

GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)

ACTIVE COMPARATOR

Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec

Drug: Magnevist

Interventions

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)

Gadobutrol 0.1 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875)

Magnevist DRUG

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

GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (4)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The 1st Affiliated Hosp of the 4th Military Med Uni

Xi'an, Shaanxi, 710032, China

Location

Chinese PLA General Hosp.

Beijing, 100853, China

Location

Fudan University Huashan Hospital

Shanghai, 200040, China

Location

Related Publications (1)

• Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28

  RESULT

MeSH Terms

Conditions

Central Nervous System Diseases; Spinal Diseases

Interventions

gadobutrol; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Nervous System Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 3, 2006
• Study Start: September 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 8, 2015
• Results First Posted: November 1, 2011

Record last verified: 2015-05

Locations

CN (4)