Trial Condition(s):

Brain Diseases, Spinal Cord Diseases

Dose finding study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Bayer Identifier:

91400

ClinicalTrials.gov Identifier:

NCT00862459

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
237
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Emory University School of Medicine

Atlanta, United States, 30322

Status
Terminated
 
Locations

Hospital of the University of Pennsylvania

Philadelphia, United States, 19104

Status
Completed
 
Locations

NYU Langone Medical Center

New York, United States, 10016

Status
Completed
 
Locations

University of Washington Medical Center

Seattle, United States, 98195

Status
Completed
 
Locations

Johns Hopkins University School of Medicine

Baltimore, United States, 21287

Status
Terminated
 
Locations

Northwestern Memorial Hospital

Chicago, United States, 60611

Status
Terminated
 
Locations

Indiana Neuroscience Institute

Indianapolis, United States, 46260

Status
Completed
 
Locations

University of California Davis Medical Center

Sacramento, United States, 95817

Status
Completed
 
Locations

Methodist Le Bonheur Healthcare

Memphis, United States, 38104

Status
Terminated
 
Locations

TCba Salguero

Buenos Aires, Argentina

Status
Completed
 
Locations

Hospital da Beneficiência Portuguesa

Sao Paulo, Brazil, 01323-001

Status
Completed
 
Locations

DIME Clinica Neurocardiovascular S.A.

Cali, Colombia

Status
Completed
 
Locations

Fundacion Cientifica del Sur

Lornas de Zamora, Argentina, B1832BQS

Status
Terminated
 
Locations

Shands Jacksonville Medical Center

Jacksonville, United States, 32209

Status
Completed
 
Locations

CENTRO DE DIAGNOSTICO MEDICO

Medellín, Colombia

Status
Completed
 
Locations

University of North Carolina

Chapel Hill, United States, 27599

Status
Terminated
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

University of Wisconsin - Madison

Madison, United States, 53792

Status
Terminated
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213

Status
Completed
 
Locations

Rhode Island Hospital

Providence, United States, 02903

Status
Completed
 
Locations

Methodist Hospital

Omaha, United States, 68114

Status
Terminated
 
Locations

Boston Medical Center

Boston, United States, 02118

Status
Completed
 
Locations

University of California-San Diego Medical Center

San Diego, United States, 92103

Status
Completed
 
Locations

Temple University Hospital

Philadelphia, United States, 19146

Status
Completed
 
Locations

Fundación Clínica Valle del Lili

Cali, Colombia

Status
Completed
 
Locations

Fundacion Cientifica del Sur

Lornas de Zamora, Argentina, B1832BQS

Status
Completed
 
Locations

Medical University of South Carolina

Charleston, United States, 29425

Status
Completed
 
Locations

Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Colombia

Status
Completed
 

Trial Design