Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

NCT ID: NCT00862459

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-03-31

Brief Summary

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 with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Detailed Description

Safety issues are addressed in the Adverse Events section

Conditions

Brain Diseases; Spinal Cord Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Group Type: EXPERIMENTAL

Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

OptiMARK~0.1 mmol/kg BW

Intervention Type: DRUG

Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

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

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Group Type: EXPERIMENTAL

Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

OptiMARK~0.1 mmol/kg BW

Intervention Type: DRUG

Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Group Type: EXPERIMENTAL

Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Intervention Type: DRUG

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

OptiMARK~0.1 mmol/kg BW

Intervention Type: DRUG

Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Interventions

Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Intervention Type: DRUG

Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Intervention Type: DRUG

Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)

Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Intervention Type: DRUG

OptiMARK~0.1 mmol/kg BW

Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS.
• Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population

Exclusion Criteria

• Is a female patient who is pregnant or nursing.
• Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.
• Has received any investigational product within 30 days prior to enrolling in this study.
• Has been previously enrolled in this study or any other study using gadobutrol.
• Has any contraindication to the MRI examinations.
• Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
• Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.
• Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).
• Has been treated with high dose (>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.
• Is scheduled to receive chemotherapy or radiotherapy during the study period.
• Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.
• Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.
• Has severe cardiovascular disease.
• Has any contraindication to OptiMARK according to the package insert.
• Has more than 30 brain lesions detected by any prior imaging examination.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

University of California Davis Medical Center

Sacramento, California, United States

University of California-San Diego Medical Center

San Diego, California, United States

Shands Jacksonville Medical Center

Jacksonville, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Indiana Neuroscience Institute

Indianapolis, Indiana, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Methodist Hospital

Omaha, Nebraska, United States

NYU Langone Medical Center

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Methodist Le Bonheur Healthcare

Memphis, Tennessee, United States

University of Washington Medical Center

Seattle, Washington, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

TCba Salguero

Buenos Aires, Buenos Aires, Argentina

Fundacion Cientifica del Sur

Lornas de Zamora, Buenos Aires, Argentina

Hospital da Beneficiência Portuguesa

São Paulo, São Paulo, Brazil

Centro de Diagnostico Medico

Medellín, Antioquia, Colombia

Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Antioquia, Colombia

DIME Clinica Neurocardiovascular S.A.

Cali, Valle del Cauca Department, Colombia

Fundación Clínica Valle del Lili

Cali, , Colombia

Countries

United States; Argentina; Brazil; Colombia

References

Breuer J, Gutierrez J, Latchaw R, Lehr R, Sorensen AG. Gadobutrol in the central nervous system at three doses: results from a phase II, randomized, multicenter trial. J Magn Reson Imaging. 2014 Feb;39(2):410-8. doi: 10.1002/jmri.24180. Epub 2013 May 16.

Reference Type: DERIVED

PMID: 23681501 (View on PubMed)

Other Identifiers

308200

Identifier Type: OTHER

Identifier Source: secondary_id

91400

Identifier Type: -

Identifier Source: org_study_id