Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Public ClinicalTrials.gov record NCT00862459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT00862459
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Bayer
- Industry
- Enrollment
- 237 participants
Conditions and interventions
Conditions
Interventions
- Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug
- Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug
- Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug
- OptiMARK~0.1 mmol/kg BW Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2005
- Primary completion
- Feb 28, 2007
- Completion
- Feb 28, 2007
- Last update posted
- Jan 12, 2014
2005 – 2007
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California-San Diego Medical Center | San Diego | California | 92103 | — |
| Shands Jacksonville Medical Center | Jacksonville | Florida | 32209 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Indiana Neuroscience Institute | Indianapolis | Indiana | 46260 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Methodist Hospital | Omaha | Nebraska | 68114 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19146 | — |
| University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Methodist Le Bonheur Healthcare | Memphis | Tennessee | 38104 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00862459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2014 · Synced Jun 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00862459 live on ClinicalTrials.gov.