Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 15 for:    Florbetaben | "Amyloidosis"

Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01020838
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : March 25, 2015
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):
Life Molecular Imaging SA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Alzheimer Disease
Intervention Drug: Florbetaben (BAY94-9172)
Enrollment 218
Recruitment Details Subjects were screened at 15 study centers in Australia, Germany, France, Japan, and the U.S.
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description All patients enrolling into the study
Period Title: Overall Study
Started 218
Safety Analysis Set 216 [1]
Interim Analysis Set (Primary Efficacy) 41 [2]
Final Analysis Set (Whole Brain) 97 [3]
First Annual Repeat Injection 91 [4]
Second Annual Repeat Injection 34 [5]
Completed 35
Not Completed 183
Reason Not Completed
Death             90
Adverse Event             1
Withdrawal by Subject             9
Lost to Follow-up             6
Most common: Study ended by sponsor             77
[1]
Two patients were excluded from this population because injection of florbetaben was not done.
[2]
Primary efficacy analysis of initial study period (tissue-scan matched regional analysis)
[3]
Final analysis set comparing PET scans with different histopathological evaluations.
[4]
Patients returning for first follow-up administration and PET-scan.
[5]
Patients returning for second follow-up administration and PET-scan.
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description All study participants who received any amount of florbetaben were included in the safety analysis set.
Overall Number of Baseline Participants 216
Hide Baseline Analysis Population Description
Participants in the safety analysis set were treated with study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants
74.4  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
Female
104
  48.1%
Male
112
  51.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
Hispanic or Latino
3
   1.4%
Not Hispanic or Latino
213
  98.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants
American Indian or Alaska Native
0
   0.0%
Asian
55
  25.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   0.9%
White
159
  73.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
BMI (kg/m^2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 216 participants
23.617  (5.213)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 216 participants
64.95  (18.44)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 216 participants
164.70  (12.34)
Baseline clinical diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 216 participants
Alzheimer's Disease 137
Dementia with Lewy bodies 5
Other dementia subject 31
Healthy volunteers 32
Healthy negative control 11
1.Primary Outcome
Title 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
Hide Description 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 β-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 β-amyloid and “abnormal” presence of β-amyloid. Sensitivity was defined as the percentage of abnormal brain regions from all regions where an SOT was available and the SOT was "β-amyloid present". Specificity was defined as the percentage of normal brain regions from all regions where an SOT was available and was "β-amyloid not present".
Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants included in the Interim Analysis Set were included in this analysis.
Arm/Group Title Sensitivity (Interim Analysis Set) Specificity (Interim Analysis Set)
Hide Arm/Group Description:
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: percentage of regions
Total 77.36 94.20
Frontal Cortex 85.71 95.00
Occipital Cortex 88.89 86.36
Hippocampus 57.14 100.00
Anterior Cingulate Cortex 90.00 85.71
Posterior Cingulate Cortex 81.82 94.44
Cerebellar Cortex 0.00 100.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sensitivity (Interim Analysis Set)
Comments

For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.

The following hypothesis was formulated for sensitivity:

H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity > 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity
Estimated Value 0.774
Confidence Interval (2-Sided) 95%
0.654 to 0.894
Estimation Comments Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Specificity (Interim Analysis Set)
Comments

For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.

The following hypothesis was formulated for specificity:

H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity > 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Specificity
Estimated Value 0.942
Confidence Interval (2-Sided) 95%
0.886 to 0.998
Estimation Comments Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT
2.Secondary Outcome
Title Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1).
Hide Description

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 β-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 "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".

Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining (SOT 1).
Arm/Group Title Full Analysis Set Final Clinical Study Report
Hide Arm/Group Description:
The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
Overall Number of Participants Analyzed 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Sensitivity
96.49
(91.71 to 100.00)
Specificity
85.00
(73.93 to 96.07)
3.Secondary Outcome
Title Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2).
Hide Description

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 β-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 "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".

Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral neuritic β-amyloid Plaques Compared with the Histopathological Verification with Bielschowsky silver staining and immunohistochemistry (SOT 2).
Arm/Group Title Full Analysis Set Final Clinical Study Report
Hide Arm/Group Description:
The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
Overall Number of Participants Analyzed 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Sensitivity
96.72
(92.25 to 100.00)
Specificity
94.44
(86.96 to 100.00)
4.Secondary Outcome
Title Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3).
Hide Description

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 β-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 "β-amyloid present". The specificity was defined as the proportion of brains classified as normal from all brains where this SOT was available and was "β-amyloid not present".

Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral β-amyloid Plaques Compared with the Histopathological Verification according to CERAD Criteria (SOT 3).
Arm/Group Title Full Analysis Set Final Clinical Study Report
Hide Arm/Group Description:
The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
Overall Number of Participants Analyzed 97
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Sensitivity
96.49
(91.71 to 100.00)
Specificity
85.00
(73.93 to 96.07)
5.Secondary Outcome
Title Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.
Hide Description 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 β-amyloid present yes/no according to the respective SOT was derived based on ROC curve analyses and used to calculate sensitivity and specificity.
Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
Sensitivity and Specificity of the subject level Composite SUVR with three different SOTs.
Arm/Group Title Sensitivity of Subject Level Composite SUVR by SOT Specificity of Subject Level Composite SUVR by SOT
Hide Arm/Group Description:
The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
Overall Number of Participants Analyzed 96 96
Measure Type: Number
Unit of Measure: percentage of subjects
SOT 1 (initial period) 89 82
SOT 2 (initial period) 90 91
SOT 3 (initial period) 89 90
SOT 1 (last available scan) 88 85
SOT 2 (last available scan) 89 94
SOT 3 (last available scan) 95 87
6.Secondary Outcome
Title Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans
Hide Description 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.
Time Frame 90-110 minutes post injection (PET image acquisition)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Initial Drug Administration 1st Repeat Drug Administration 2nd Repeat Drug Administration
Hide Arm/Group Description:
The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
The analysis set consisted of data from 20 subjects with brain specimens available.
The analysis set consisted of data from 3 subjects with brain specimens available.
Overall Number of Participants Analyzed 96 20 3
Mean (Standard Deviation)
Unit of Measure: Standardized Uptake Value Ratio (SUVR)
SOT 1 (abeta absent) 1.296  (0.232) 1.319  (0.414) 1.537 [1]   (NA)
SOT 1 (abeta present) 1.707  (0.276) 1.625  (0.250) 1.699  (0.046)
SOT 2 (abeta absent) 1.237  (0.140) 1.175  (0.364) 1.537 [1]   (NA)
SOT 2 (abeta present) 1.714  (0.273) 1.632  (0.244) 1.699  (0.046)
SOT 3 (abeta absent) 1.263  (0.170) 1.260  (0.390) NA [1]   (NA)
SOT 3 (abeta present) 1.729  (0.270) 1.639  (0.236) 1.645  (0.099)
[1]
Sample size too low
Time Frame All treatment emergent adverse events were recorded within 7 days of the application or follow-up application of study drug.
Adverse Event Reporting Description As this study was conducted in an end-of-life population, death occurring outside 7 day follow-up period after administration of the drug was not collected as part of the study SAE data unless investigator considered the event to be related to drug administration or study procedure.
 
Arm/Group Title Initial Drug Administration 1st Repeat Drug Administration 2nd Repeat Drug Administration
Hide Arm/Group Description Subjects with TEAEs within 7 days of the initial administration of florbetaben. Subjects with TEAEs within 7 days of the 1st repeat drug administration. Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
All-Cause Mortality
Initial Drug Administration 1st Repeat Drug Administration 2nd Repeat Drug Administration
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Initial Drug Administration 1st Repeat Drug Administration 2nd Repeat Drug Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/216 (5.56%)      0/91 (0.00%)      0/34 (0.00%)    
Cardiac disorders       
Cardiac Failure * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Gastrointestinal disorders       
Colitis * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Colon cancer * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
General disorders       
Heat stroke * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Oedema peripheral * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Hepatobiliary disorders       
Hepatic cancer metastatic * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Infections and infestations       
Pneumonia * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Pneumonia aspiration * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Injury, poisoning and procedural complications       
Pubis fracture * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Spinal compression fracture * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Arthralgia * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Nervous system disorders       
Frontotemporal dementia * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Dementia, Alzheimers' type * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Convulsion * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Psychiatric disorders       
Delirium * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratory failure * 1  1/216 (0.46%)  1 0/91 (0.00%)  0 0/34 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Initial Drug Administration 1st Repeat Drug Administration 2nd Repeat Drug Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/216 (22.22%)      22/91 (24.18%)      14/34 (41.18%)    
Gastrointestinal disorders       
Frequent bowel movements * 1  1/216 (0.46%)  1 1/91 (1.10%)  1 0/34 (0.00%)  0
General disorders       
Injection site erythema * 1  4/216 (1.85%)  4 0/91 (0.00%)  0 1/34 (2.94%)  1
Injection site pain * 1  4/216 (1.85%)  4 0/91 (0.00%)  0 0/34 (0.00%)  0
Puncture site reaction * 1  7/216 (3.24%)  7 4/91 (4.40%)  4 0/34 (0.00%)  0
Pyrexia * 1  7/216 (3.24%)  8 2/91 (2.20%)  2 0/34 (0.00%)  0
Injection site hematoma * 1  10/216 (4.63%)  10 1/91 (1.10%)  1 0/34 (0.00%)  0
Injection site hemorrhage * 1  1/216 (0.46%)  1 4/91 (4.40%)  4 2/34 (5.88%)  2
Injection site bruising * 1  5/216 (2.31%)  5 0/91 (0.00%)  0 0/34 (0.00%)  0
Vessel puncture site swelling * 1  1/216 (0.46%)  1 1/91 (1.10%)  1 1/34 (2.94%)  1
Infections and infestations       
Cystitis * 1  0/216 (0.00%)  0 0/91 (0.00%)  0 1/34 (2.94%)  1
Injury, poisoning and procedural complications       
Procedural pain * 1  0/216 (0.00%)  0 1/91 (1.10%)  1 0/34 (0.00%)  0
Procedural hypertension * 1  0/216 (0.00%)  0 0/91 (0.00%)  0 1/34 (2.94%)  1
Investigations       
Blood pressure increased * 1  3/216 (1.39%)  3 1/91 (1.10%)  1 0/34 (0.00%)  0
Nervous system disorders       
Headache * 1  3/216 (1.39%)  3 0/91 (0.00%)  0 0/34 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/216 (0.00%)  0 0/91 (0.00%)  0 1/34 (2.94%)  1
Emphysema * 1  0/216 (0.00%)  0 0/91 (0.00%)  0 1/34 (2.94%)  1
Skin and subcutaneous tissue disorders       
Haemorrhage subcutaneous * 1  1/216 (0.46%)  1 3/91 (3.30%)  3 1/34 (2.94%)  1
Erythema * 1  1/216 (0.46%)  1 4/91 (4.40%)  5 3/34 (8.82%)  3
Rash * 1  2/216 (0.93%)  3 1/91 (1.10%)  1 0/34 (0.00%)  0
Papule * 1  0/216 (0.00%)  0 1/91 (1.10%)  1 0/34 (0.00%)  0
Vascular disorders       
Hypertension * 1  5/216 (2.31%)  5 1/91 (1.10%)  1 1/34 (2.94%)  1
Haematoma * 1  1/216 (0.46%)  1 5/91 (5.49%)  5 6/34 (17.65%)  6
Hypotension * 1  3/216 (1.39%)  3 0/91 (0.00%)  0 0/34 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Juergen Hirschfeld
Organization: Piramal Imaging
Phone: 49 30 461 1246 15
Responsible Party: Life Molecular Imaging SA
ClinicalTrials.gov Identifier: NCT01020838     History of Changes
Other Study ID Numbers: 14595
2009-012569-79 ( EudraCT Number )
First Submitted: November 16, 2009
First Posted: November 26, 2009
Results First Submitted: February 2, 2015
Results First Posted: March 25, 2015
Last Update Posted: May 27, 2016