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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain Diseases, Spinal Cord Diseases

Thank you

Trial Information

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


Safety issues are addressed in the Adverse Events section


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Categorical Visualization Score (CVS)

Outcome Description:

The primary visualization variables (number [no.] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded readers, producing 1 mean CVS per participant. The higher the CVS, the more effective the treatment.

Outcome Time Frame:

up to 2 hours after the injection of study medication

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

91400

NCT ID:

NCT00862459

Start Date:

August 2005

Completion Date:

March 2007

Related Keywords:

  • Brain Diseases
  • Spinal Cord Diseases
  • Contrast Agents
  • Brain Diseases
  • Spinal Cord Diseases

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
University of California Davis Medical CenterSacramento, California  95817
Rhode Island HospitalProvidence, Rhode Island  02903
Northwestern Memorial HospitalChicago, Illinois  60611
Boston Medical CenterBoston, Massachusetts  02118
Emory University School of MedicineAtlanta, Georgia  30322
Temple University HospitalPhiladelphia, Pennsylvania  19140
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
University of North CarolinaChapel Hill, North Carolina  27599
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Shands Jacksonville Medical CenterJacksonville, Florida  32209
University of California-San Diego Medical CenterLa Jolla, California  
University of Pittsburgh Medical Center Health SystemPittsburgh, Pennsylvania  15213
NYU Langone Medical CenterNew York, New York  10016
Indiana Neuroscience InstituteIndianapolis, Indiana  46260
Methodist HospitalOmaha, Nebraska  68114
Methodist Le Bonheur HealthcareMemphis, Tennessee  38104
University of Wisconsin - MadisonMadison, Wisconsin  53792