AzTrials
AzTrials

Brain DiseasesPhase 2NCT00862459

Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

A Phase 2 study testing Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) and Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) in people with Brain Diseases and Spinal Cord Diseases, run by Bayer at 27 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Diseases, Spinal Cord Diseases
What is being tested?
Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) and Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
237 participants
Where
27 sitesin 4 countries
Study dates
Aug 2005to Mar 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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 locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

United States20 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Indiana Neuroscience Institute

    Indianapolis, Indiana, 46260

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • Methodist Le Bonheur Healthcare

    Memphis, Tennessee, 38104

  • NYU Langone Medical Center

    New York, New York, 10016

  • Methodist Hospital

    Omaha, Nebraska, 68114

  • 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

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • University of California-San Diego Medical Center

    San Diego, California, 92103

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Colombia4 sites

  • DIME Clinica Neurocardiovascular S.A.

    Cali, Valle del Cauca Department

  • Fundación Clínica Valle del Lili

    Cali

  • Centro de Diagnostico Medico

    Medellín, Antioquia

  • Fundación Instituto de Alta tecnología médica de Antioquia

    Medellín, Antioquia

Other trials in Colombia

Argentina2 sites

  • TCba Salguero

    Buenos Aires, Buenos Aires

  • Fundacion Cientifica del Sur

    Lornas de Zamora, Buenos Aires, B1832BQS

Other trials in Argentina

Brazil1 site

  • Hospital da Beneficiência Portuguesa

    São Paulo, São Paulo, 01323-001

Other trials in Brazil

About this study

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

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.

Read the detailed description

Safety issues are addressed in the Adverse Events section

Being tested
Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), OptiMARK~0.1 mmol/kg BW
Keywords
Contrast Agents
Medical subject headings
Brain Diseases, Spinal Cord Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)Drug

    Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

  • Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)Drug

    Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

  • Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)Drug

    Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

  • OptiMARK~0.1 mmol/kg BWDrug

    Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.

Study groups in NCT00862459
Study groupRoleWhat they receive
Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Receives: Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Drug: OptiMARK~0.1 mmol/kg BW
Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Receives: Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Drug: OptiMARK~0.1 mmol/kg BW
Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
Receives: Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875); Drug: OptiMARK~0.1 mmol/kg BW

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Categorical Visualization Score (CVS)

    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.

    Measured: up to 2 hours after the injection of study medication

  2. Difference in Number of Lesions Detected in Pre-contrast and Combined Pre-/Post-contrast MRI.

    Three blinded readers evaluated the unenhanced MRI sets and the combined unenhanced/gadobutrol-enhanced MRI sets to evaluate the number of lesions, which was then averaged to produce an average reader value.

    Measured: up to 2 hours after the injection of study medication

  3. Assessment of Lesion Contrast Enhancement

    The blinded readers assessed the degree of contrast enhancement for each lesion on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement, which was then averaged to produce an average reader score.

    Measured: up to 2 hours after the injection of study medication

  4. Assessment of Border Delineation

    The blinded readers assessed the delineation for each lesion on a 4-point scale where 1 = none and 4 = excellent, which was then averaged to produce an average reader score.

    Measured: up to 2 hours after the injection of study medication

  5. Assessment of Internal Morphology

    The blinded readers assessed the degree of information available about internal morphology and structure for each lesion on a 3-point scale where 1 = poor and 3 = good, which was then averaged to produce an average reader score.

    Measured: up to 2 hours after the injection of study medication

  6. Contrast to Noise Ratio (CNR) Between White and Gray Matter With Gadobutrol Perfusion MRI

    CNR between white and gray matter in the perfusion imaging was defined as the signal intensity (SI) difference between white and gray matter divided by the standard deviation of the SI of white matter. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.

    Measured: up to 2 hours after the injection of study medication

Secondary outcomes (40)

  1. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 1

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for blinded reader (BR) 1.

    Measured: up to 2 hours after the injection of study medication

  2. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 2

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 2

    Measured: up to 2 hours after the injection of study medication

  3. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Lesions: Blinded Reader 3

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched lesions was performed for BR 3

    Measured: up to 2 hours after the injection of study medication

  4. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 1

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 1

    Measured: up to 2 hours after the injection of study medication

  5. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 2

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 2

    Measured: up to 2 hours after the injection of study medication

  6. Accuracy Comparison of Gadobutrol Doses - Detection of Matched Enhanced Lesions: Blinded Reader 3

    The percent accuracy (total number of lesions matching the comparator divided by the total number of lesions identified by gadobutrol) comparison of the 0.03 and 0.1 mmol/kg gadobutrol doses and the 0.1 and 0.3 mmol/kg gadobutrol doses using detection of all comparator-detected matched enhanced lesions was performed for BR 3

    Measured: up to 2 hours after the injection of study medication

  7. Evaluation of the Correct Diagnosis Following Gadobutrol-enhanced and Unenhanced MRI

    The gadobutrol-enhanced and unenhanced MRI diagnoses of the average reader were compared to the final diagnosis.

    Measured: up to 2 hours after the injection of study medication

  8. Evaluation of the Diagnostic Confidence Based on Unenhanced MRI and Combined Unenhanced and Enhanced MRI

    The diagnostic confidence, the level of certainty in a diagnosis, was determined based on the average of the blinded readers.

    Measured: up to 2 hours after the injection of study medication

  9. Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume [CBV]) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  10. Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  11. Evaluation of Perfusion Map Quality (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the uncorrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  12. Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  13. Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  14. Evaluation of Perfusion Map Quality (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the corrected CBV perfusion map.

    Measured: up to 2 hours after the injection of study medication

  15. Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the CBF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  16. Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the CBF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  17. Evaluation of Perfusion Map Quality (Cerebral Blood Flow (CBF)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the CBF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  18. Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the TTP perfusion map.

    Measured: up to 2 hours after the injection of study medication

  19. Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the TTP perfusion map.

    Measured: up to 2 hours after the injection of study medication

  20. Evaluation of Perfusion Map Quality (Time to Peak (TTP)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the TTP perfusion map.

    Measured: up to 2 hours after the injection of study medication

  21. Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the MTT perfusion map.

    Measured: up to 2 hours after the injection of study medication

  22. Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the MTT perfusion map.

    Measured: up to 2 hours after the injection of study medication

  23. Evaluation of Perfusion Map Quality (Mean Transit Time (MTT)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the MTT perfusion map.

    Measured: up to 2 hours after the injection of study medication

  24. Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 1

    BR 1 evaluated the visibility of the lesion(s) on the PF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  25. Evaluation of Perfusion Map Quality (Permeability Factor (PF) - Blinded Reader 2

    BR 2 evaluated the visibility of the lesion(s) on the PF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  26. Evaluation of Perfusion Map Quality (Permeability Factor (PF)) - Blinded Reader 3

    BR 3 evaluated the visibility of the lesion(s) on the PF perfusion map.

    Measured: up to 2 hours after the injection of study medication

  27. Evaluation of Perfusion Map Parameter Value (Uncorrected Cerebral Blood Volume (CBV)) - Independent Radiologist

    The independent radiologist determined the uncorrected CBV for each lesion. CBV is the volume of blood in the tissue.

    Measured: up to 2 hours after the injection of study medication

  28. Evaluation of Perfusion Map Parameter Value (Corrected Cerebral Blood Volume (CBV)) - Independent Radiologist

    The independent radiologist determined the corrected CBV for each lesion. CBV is the volume of blood in the tissue.

    Measured: up to 2 hours after the injection of study medication

  29. Evaluation of Perfusion Map Parameter Value (Cerebral Blood Flow (CBF)) - Independent Radiologist

    The independent radiologist determined the CBF for each lesion. CBF is the volume of blood passing through tissue per unit of time.

    Measured: up to 2 hours after the injection of study medication

  30. Evaluation of Perfusion Map Parameter Value (Time to Peak (TTP)) - Independent Radiologist

    The independent radiologist determined the TTP for each lesion. TTP is the delay between the arrival of the contrast agent bolus arrival time and the peak of the concentration curve.

    Measured: up to 2 hours after the injection of study medication

  31. Evaluation of Perfusion Map Parameter Value (Mean Transit Time (MTT)) - Independent Radiologist

    The independent radiologist determined the MTT for each lesion. The MTT is the time (seconds) for contrast to pass through tissues.

    Measured: up to 2 hours after the injection of study medication

  32. Evaluation of Perfusion Map Parameter Value (Permeability Factor (PF)) - Independent Radiologist

    The independent radiologist determined the PF for each lesion

    Measured: up to 2 hours after the injection of study medication

  33. Evaluation of Perfusion Map Artifacts (Uncorrected Cerebral Blood Volume (CBV)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the uncorrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time.

    Measured: up to 2 hours after the injection of study medication

  34. Evaluation of Perfusion Map Artifacts (Corrected Cerebral Blood Volume (CBV)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the corrected CBV perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time. CBV is the fraction of the tissue volume occupied by the blood.

    Measured: up to 2 hours after the injection of study medication

  35. Evaluation of Perfusion Map Artifacts (Cerebral Blood Flow (CBF)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the CBF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time

    Measured: up to 2 hours after the injection of study medication

  36. Evaluation of Perfusion Map Artifacts (Time to Peak (TTP)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the TTP perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time

    Measured: up to 2 hours after the injection of study medication

  37. Evaluation of Perfusion Map Artifacts (Mean Transit Time (MTT)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the MTT perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time

    Measured: up to 2 hours after the injection of study medication

  38. Evaluation of Perfusion Map Artifacts (Permeability Factor (PF)) - Blinded Reader

    The blinded reader evaluated if artifacts were present on the PF perfusion map and recorded the type of the major artifact. EPI: echo-planar imaging; T2: transversal relaxation time

    Measured: up to 2 hours after the injection of study medication

  39. Evaluation of MRI Tumor Grade Agreement With Biopsy Results by Dose Group

    The blinded readers gave an estimation of the tumor grade of brain tumors (low grade [I or II] or high grade [III or IV]) in terms of malignancy using the information obtained by perfusion imaging, which was compared to the biopsy sample results

    Measured: up to 2 hours after the injection of study medication

  40. Contrast to Noise Ratio (CNR) of Lesion/Gray Matter and Lesion/White Matter

    CNR between lesion/gray matter and lesion/white matter in the perfusion imaging was defined as the signal intensity (SI) difference between lesion and gray or white matter divided by the standard deviation of background noise. An independent radiologist evaluated the gadobutrol-enhanced perfusion MRI for signal intensity.

    Measured: up to 2 hours after the injection of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2009 (estimated)
  2. Study startAug 2005
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00862459
Sponsor's protocol ID
91400
Other IDs
308200
Status last verified
Dec 2013
First submitted
26 Nov 2008
Last updated
13 Jan 2014
Data monitoring committee
No

Publications

  • Breuer J, Gutierrez J, Latchaw R, Lehr R, Sorensen AG. Gadobutrol in the central nervous system at three doses: results from a phase II, randomized, multicenter trial. J Magn Reson Imaging. 2014 Feb;39(2):410-8. doi: 10.1002/jmri.24180. Epub 2013 May 16.

    PubMed 23681501

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) and Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) in people with Brain Diseases and Spinal Cord Diseases, run by Bayer at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Colombia, Argentina, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical Visualization Score (CVS) (time frame: up to 2 hours after the injection of study medication). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00862459, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.

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