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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01020838
Registration number
NCT01020838
Ethics application status
Date submitted
16/11/2009
Date registered
26/11/2009
Date last updated
27/05/2016
Titles & IDs
Public title
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral ß-amyloid Compared to Histopathology
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Scientific title
An Open-label, Non-randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology
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Secondary ID [1]
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2009-012569-79
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Secondary ID [2]
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14595
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Florbetaben (BAY94-9172)
Experimental: Florbetaben (BAY94-9172) -
Treatment: Drugs: Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml, 300 MBq (+/- 20%)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens
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Assessment method [1]
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The sensitivity/specificity of the visual assessment were calculated based on the majority read assessment of regional tracer uptake. This result was derived from assessments by 3 independent readers for brain regions of a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was a centralized histopathological determination of ß-amyloid presence/absence based on both Bielschowsky silver and immunohistochemical staining. Based on the PET images, a brain region was classified as "normal" or "abnormal" depending on the presence or absence of regional tracer uptake in the respective region. "Normal" therefore meant absence of ß-amyloid and "abnormal" presence of ß-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "ß-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "ß-amyloid not present".
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Timepoint [1]
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90-110 minutes post injection (PET image acquisition)
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Secondary outcome [1]
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Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic ß-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1).
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Assessment method [1]
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Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of ß-amyloid based on Bielschowsky silver staining (SOT 1).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "ß-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "ß-amyloid not present".
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Timepoint [1]
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90-110 minutes post injection (PET image acquisition)
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Secondary outcome [2]
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Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic ß-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2).
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Assessment method [2]
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Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a centralized histopathological assessment of the presence/absence of ß-amyloid based on Bielschowsky silver staining and immunohistochemistry (SOT 2).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "ß-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "ß-amyloid not present".
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Timepoint [2]
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90-110 minutes post injection (PET image acquisition)
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Secondary outcome [3]
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Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic ß-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3).
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Assessment method [3]
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Sensitivity and specificity of the whole brain visual assessment were calculated. Any brain with a region classified as abnormal from PET imaging was to be classified as abnormal for the "whole brain" assessment. This result was derived from assessments by 3 independent readers for a subject where a Standard of Truth (SOT) was available. The SOT for this analysis was based on a histopathological assessment of the presence/absence of ß-amyloid according to CERAD Criteria (SOT 3).
The sensitivity was defined as the proportion of brains classified as abnormal from all brains where this SOT was available and was "ß-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "ß-amyloid not present".
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Timepoint [3]
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90-110 minutes post injection (PET image acquisition)
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Secondary outcome [4]
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Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
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Assessment method [4]
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Sensitivity and specificity of subject level composite Standard Uptake Value Ratios (SUVR) by SOT for subjects with available brain tissue and 10 healthy volunteers. The SUVR were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of the tissue radioactivity concentration c (in MBq/kg) at time point t, and the injected activity (in MBq), extrapolated to the same time (t) divided by the body weight (in kg). SUV numbers were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference. SOTs comprised Bielschowsky silver staining (SOT 1), Bielschowsky silver staining with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans. The optimal threshold for the distinction between ß-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.
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Timepoint [4]
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90-110 minutes post injection (PET image acquisition)
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Secondary outcome [5]
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Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
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Assessment method [5]
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Subject level composite SUVRs (calculated as mean of SUVRs from the frontal, parietal, lateral temporal, anterior and posterior cingulate, and occipital cortices) by SOT are reported for subjects with available brain tissue. The initial drug administration group includes additionally 10 healthy controls who were considered as ß-amyloid negative. The SOTs for deceased subjects were based on Bielschowsky silver staining (SOT 1), Bielschowsky silver staining in combination with immunohistochemistry (SOT 2) and neuropathology assessment according to CERAD (SOT 3). SUVR analysis was performed for baseline and available follow-up scans.
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Timepoint [5]
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90-110 minutes post injection (PET image acquisition)
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Eligibility
Key inclusion criteria
- Females, no child-bearing potential or negative urine pregnancy test on day of
BAY94-9172 injection
- Exhibits visual, auditory, and communicative capabilities adequate to provide informed
consent or assent and comply with study procedures
- Is willing and able to lie down in magnetic resonance imaging (MRI) and positron
emission tomography (PET) scanners
- Is willing to donate their brain for postmortem examination in case of death
- The subject, or the subject and/or legally acceptable representative will be compliant
and have a high probability of completing the study in the opinion of the investigator
- Has been fully informed about the study, including provisions of the Health Insurance
Portability and Accountability Act (HIPAA), as applicable, and informed consent or
assent has been signed and dated (with time) by the subject and/or the subject's
legally acceptable representative
- The subjects who have participated in a previous florbetaben study e.g. study 311741
may be included in the present study. The MRI- and florbetaben PET scan do not need to
be repeated if both scans were performed within twelve months prior to inclusion.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has severe cerebral macrovascular (ie, multi-stroke) disease or brain tumor
(metastasis/brain cancer) as verified by MRI
- Has any contraindication to magnetic resonance imaging (MRI) examination, eg, metal
implants or phobia as determined by the onsite radiologist performing the scan
- Has been previously enrolled in this study or participated in a clinical study
involving an investigational pharmaceutical product within 30 days prior to screening
and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior
to study drug administration in this study
- Has severe cardio-vascular instability requiring intensive care surveillance and/or
therapeutic intervention (i.e. catecholamine infusion)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
218
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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New Jersey
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Country [5]
0
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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France
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State/province [7]
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Lille
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Country [8]
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France
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State/province [8]
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Strasbourg
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Country [9]
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Germany
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State/province [9]
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Nordrhein-Westfalen
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Country [10]
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Germany
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State/province [10]
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Sachsen
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Country [11]
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Japan
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State/province [11]
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Aichi
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Country [12]
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Japan
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State/province [12]
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Gunma
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Country [13]
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Japan
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State/province [13]
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Shizuoka
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Country [14]
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Japan
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State/province [14]
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Tokyo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Life Molecular Imaging SA
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To determine the sensitivity and specificity of the visual assessment of tracer uptake in the
Florbetaben PET images compared to histological verification of the presence or absence of
cerebral ß-amyloid in the respective histopathologic post mortem specimens as the standard of
truth
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01020838
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Piramal Imaging SA Study Director
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Address
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Life Molecular Imaging SA
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01020838
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