Study Completed

Brain Diseases, Spinal Cord Diseases

Bayer Identifier:

91400

ClinicalTrials.gov Identifier:

NCT00862459

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 Years

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

August 2005 - March 2007

Phase

Phase 2

Could I Receive a placebo

Products

Gadavist/Gadovist (Gadobutrol, BAY86-4875)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	Emory University School of Medicine	Atlanta, 30322, United States
Completed	Hospital of the University of Pennsylvania	Philadelphia, 19104, United States
Completed	NYU Langone Medical Center	New York, 10016, United States
Completed	University of Washington Medical Center	Seattle, 98195, United States
Terminated	Johns Hopkins University School of Medicine	Baltimore, 21287, United States
Terminated	Northwestern Memorial Hospital	Chicago, 60611, United States
Completed	Indiana Neuroscience Institute	Indianapolis, 46260, United States
Completed	University of California Davis Medical Center	Sacramento, 95817, United States
Terminated	Methodist Le Bonheur Healthcare	Memphis, 38104, United States
Completed	TCba Salguero	Buenos Aires, Argentina
Completed	Hospital da Beneficiência Portuguesa	Sao Paulo, 01323-001, Brazil
Completed	DIME Clinica Neurocardiovascular S.A.	Cali, Colombia
Terminated	Fundacion Cientifica del Sur	Lornas de Zamora, B1832BQS, Argentina
Completed	Shands Jacksonville Medical Center	Jacksonville, 32209, United States
Completed	CENTRO DE DIAGNOSTICO MEDICO	Medellín, Colombia
Terminated	University of North Carolina	Chapel Hill, 27599, United States
Completed	Washington University School of Medicine	St. Louis, 63110, United States
Terminated	University of Wisconsin - Madison	Madison, 53792, United States
Completed	University of Pittsburgh Medical Center Health System	Pittsburgh, 15213, United States
Completed	Rhode Island Hospital	Providence, 02903, United States
Terminated	Methodist Hospital	Omaha, 68114, United States
Completed	Boston Medical Center	Boston, 02118, United States
Completed	University of California-San Diego Medical Center	San Diego, 92103, United States
Completed	Temple University Hospital	Philadelphia, 19146, United States
Completed	Fundación Clínica Valle del Lili	Cali, Colombia
Completed	Fundacion Cientifica del Sur	Lornas de Zamora, B1832BQS, Argentina
Completed	Medical University of South Carolina	Charleston, 29425, United States
Completed	Fundación Instituto de Alta tecnología médica de Antioquia	Medellín, Colombia

Primary Outcome

Categorical Visualization Score (CVS)
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Difference in number of lesions detected in pre-contrast and combined pre-/post-contrast MRI
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Assessment of Lesion Contrast Enhancement (difference)
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Assessment of border delineation
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Assessment of Internal morphology
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Contrast to Noise ratio (CNR) between white and gray matter with Gadobutrol perfusion MRI
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No

Secondary Outcome

Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Accuracy comparison of Gadobutrol doses – detection of matched lesions: blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Accuracy comparison of Gadobutrol doses – detection of matched enhanced lesions: blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of the correct diagnosis following gadobutrol-enhanced and unenhanced MRI
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of the diagnostic confidence based on unenhanced MRI and combined unenhanced and enhanced MRI
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (uncorrected cerebral blood volume (CBV)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (corrected cerebral blood volume (CBV)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (cerebral blood flow (CBF)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (time to peak (TTP)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (mean transit time (MTT)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (Permeability factor (PF) – blinded reader 1
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (Permeability factor (PF) – blinded reader 2
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map quality (Permeability factor (PF)) – blinded reader 3
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (uncorrected cerebral blood volume (CBV)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (corrected cerebral blood volume (CBV)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (cerebral blood flow (CBF)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (time to peak (TTP)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (mean transit time (MTT)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map parameter value (Permeability factor (PF)) – Independent Radiologist
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (uncorrected cerebral blood volume (CBV)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (corrected cerebral blood volume (CBV)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (cerebral blood flow (CBF)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (time to peak (TTP)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (mean transit time (MTT)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of perfusion map artifacts (Permeability factor (PF)) – blinded reader
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Evaluation of MRI Tumor Grade agreement with biopsy Results by dose group
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No
Contrast to Noise Ratio (CNR) of lesion/gray matter and lesion/white matter
Time Frame:
up to 2 hours after the injection of study medication
Safety Issue:
No

Trial design

Multi-center, double-blind, randomized, controlled, parallel group, dose comparison study with corresponding blinded image evaluation following a single intravenous injection of three different doses of gadobutrol 1.0 molar (Gadavist) in patients with known or suspected focal blood brain barrier disturbances and/or abnormal vascularity of the central nervous system

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Diagnostic

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.