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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01020838
First received: November 16, 2009
Last updated: May 9, 2013
Last verified: May 2013

November 16, 2009
May 9, 2013
November 2009
September 2011   (final data collection date for primary outcome measure)
Sensitivity and specificity of the visual assessment of tracer uptake compared to histological verification of the presence or absence of cerebral beta-amyloid in postmortem specimens [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01020838 on ClinicalTrials.gov Archive Site
  • Sensitivity and specificity of the composite "whole brain" regional visual assessment in detecting/excluding cerebral β-amyloid plaques based on the "whole brain" histopathological verification of the presence/absence of ß-amyloid deposition [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the quantitative assessment of regional tracer uptake in BAY94-9172 PET images compared to histological verification of presence/absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the visual assessment of BAY 94-9172 PET images on the subject level (according to the RCTU and BAPL rating scale) in detecting/excluding cerebral β-amyloid compared to the onsite neuropathological diagnosis [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of a single dose of BAY94-9172 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Sensitivity and specificity of the quantitative assessment of tracer uptake in BAY94-9172 PET images compared to histological verification [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the visual assessment of BAY94-9172 PET images in detecting/excluding cerebral beta-amyloid compared to the clinical diagnosis [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the quantitative assessment of BAY94-9172 PET images in detecting/excluding cerebral beta-amyloid compared to the clinical diagnosis [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of a single dose of BAY94-9172 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
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

To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Alzheimer Disease
Drug: Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml
Experimental: Arm 1
Intervention: Drug: Florbetaben (BAY94-9172)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
216
August 2014
September 2011   (final data collection date for primary outcome measure)

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.

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)
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   France,   Germany,   Japan
 
NCT01020838
14595, 2009-012569-79
No
Piramal Imaging SA
Piramal Imaging SA
Not Provided
Study Director: Piramal Imaging SA Study Director Piramal Imaging SA
Piramal Imaging SA
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP