Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

NCT00623467 | Completed Phase 3 Results

• 1 other identifier: 91682
• Study Type: interventional
• Target: 343
• Locations: 5 countries
• Sites: 37

Brief Summary

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Conditions

Central Nervous System Diseases

Keywords

Central Nervous System Imaging; Diagnostic Imaging

Outcome Measures

Primary Outcomes (5)

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 1 (BR1)

  BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 2 (BR2)

  BR2 (reader 2 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Blinded Reader 3 (BR3)

  BR3 (reader 3 of 3) evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced Magnetic Resonance Imaging (MRI) Compared to Unenhanced MRI by Average Reader (AR)

  The AR analysis used the mean of the values for the 3 blinded readers. The 3 BRs evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 = sufficiently visible.

  Up to 2 hours after injection of gadobutrol

• Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Readers

  The 3 blinded readers evaluated the images from the unenhanced MRI in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another to determine the total number of lesions.

  Up to 2 hours after injection of gadobutrol

Secondary Outcomes (26)

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator

  Up to 2 hours after injection of gadobutrol

• Number of Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Clinical Investigator

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 1 (BR1)

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 2 (BR2)

  Up to 2 hours after injection of gadobutrol

• Scores for Three Visualization Parameters (Contrast Enhancement, Border Delineation and Internal Morphology) for Lesions for Combined Unenhanced/Gadobutrol-enhanced MRI Compared to Unenhanced MRI by Blinded Reader 3 (BR3)

  Up to 2 hours after injection of gadobutrol

Study Arms (1)

Gadobutrol (Gadavist, BAY86-4875)

EXPERIMENTAL

Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same rate.

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

Interventions

Gadobutrol (Gadavist, Gadovist, BAY86-4875) DRUG

Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Gadobutrol (Gadavist, BAY86-4875)

Eligibility Criteria

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

You may qualify if:

• Patients referred for contrast enhanced MRI of the CNS based on symptoms or previous procedures.

You may not qualify if:

• Patients with acute renal insufficiency
• Patients with severe renal disease
• Patients with any contraindication to magnetic resonance imaging.

Sponsors & Collaborators

• Bayer: lead

Study Sites (37)

HOPE Research Institute, LLC

Phoenix, Arizona, 85050, United States

Location

Scottsdale Medical Imaging, Ltd.

Scottsdale, Arizona, 85258, United States

Location

Radiology Ltd.

Tucson, Arizona, 85711, United States

Location

Landmark Imaging Medical Group

Los Angeles, California, 90025, United States

Location

Cedars- Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sharp & Children's MRI Center

San Diego, California, 92123, United States

Location

University of Florida - Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

Eisenhower Army Medical Center

Fort Gordon, Georgia, 30905, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109-5302, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Bio-Magnetic Resonance, Inc.

Madison Heights, Michigan, 48071, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Hahnemann University Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Investigaciones Médicas

Buenos Aires, Ciudad Auton. de Buenos Aires, C1082A, Argentina

Location

Milbet Diagnostico por Imagenes

Buenos Aires, Ciudad Auton. de Buenos Aires, C1115AAB, Argentina

Location

Hospital Italiano Buenos Aires

Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH, Argentina

Location

Centro de Diagnóstico Dr. Enrique Rossi

Buenos Aires, Ciudad Auton. de Buenos Aires, C1425BEE, Argentina

Location

Zhongda Hosp. affiliated of Southeast Univ.

Nanjing, Jiangsu, 210009, 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

Affiliated Ruijin Hosp. Shanghai Jiaotong Univ. Med School

Shanghai, 200025, China

Location

Fudan University Huashan Hospital

Shanghai, 200040, China

Location

Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Antioquia, Colombia

Location

Fundación Santa Fe de Bogotá - Hospital Universitario

Bogotá, Cundinamarca, Colombia

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Korea, 110-744, South Korea

Location

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Interventions

gadobutrol

Condition Hierarchy (Ancestors)

Nervous System Diseases

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: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 26, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 10, 2014
• Results First Posted: October 6, 2011

Record last verified: 2014-01

Locations

CN (5); AR (4); CO (2); US (21); KR (5)