check_circleStudy 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
  • - 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
  • - 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
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Emory University School of MedicineAtlanta, 30322, United States
Completed
Hospital of the University of PennsylvaniaPhiladelphia, 19104, United States
Completed
NYU Langone Medical CenterNew York, 10016, United States
Completed
University of Washington Medical CenterSeattle, 98195, United States
Terminated
Johns Hopkins University School of MedicineBaltimore, 21287, United States
Terminated
Northwestern Memorial HospitalChicago, 60611, United States
Completed
Indiana Neuroscience InstituteIndianapolis, 46260, United States
Completed
University of California Davis Medical CenterSacramento, 95817, United States
Terminated
Methodist Le Bonheur HealthcareMemphis, 38104, United States
Completed
TCba SalgueroBuenos Aires, Argentina
Completed
Hospital da Beneficiência PortuguesaSao Paulo, 01323-001, Brazil
Completed
DIME Clinica Neurocardiovascular S.A.Cali, Colombia
Terminated
Fundacion Cientifica del SurLornas de Zamora, B1832BQS, Argentina
Completed
Shands Jacksonville Medical CenterJacksonville, 32209, United States
Completed
CENTRO DE DIAGNOSTICO MEDICOMedellín, Colombia
Terminated
University of North CarolinaChapel Hill, 27599, United States
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Terminated
University of Wisconsin - MadisonMadison, 53792, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213, United States
Completed
Rhode Island HospitalProvidence, 02903, United States
Terminated
Methodist HospitalOmaha, 68114, United States
Completed
Boston Medical CenterBoston, 02118, United States
Completed
University of California-San Diego Medical CenterSan Diego, 92103, United States
Completed
Temple University HospitalPhiladelphia, 19146, United States
Completed
Fundación Clínica Valle del LiliCali, Colombia
Completed
Fundacion Cientifica del SurLornas de Zamora, B1832BQS, Argentina
Completed
Medical University of South CarolinaCharleston, 29425, United States
Completed
Fundación Instituto de Alta tecnología médica de AntioquiaMedellín, Colombia

Primary Outcome

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

Secondary Outcome

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

Additional Information

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