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Trial record 1 of 1 for:    NCT02090855
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Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

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ClinicalTrials.gov Identifier: NCT02090855
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : August 27, 2014
Last Update Posted : March 27, 2017
Sponsor:
Collaborators:
Covance
H2O Clinical LLC
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.

Condition or disease
Cognitive Impairment

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem.
Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Group/Cohort
Flutemetamol (18F)
There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007.



Primary Outcome Measures :
  1. The Number of Abnormal Blinded Visual PET Image Interpretations. [ Time Frame: Brain images will be assessed up to 1 year post subject's death. ]
    Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.

  2. Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans [ Time Frame: Brain images will be assessed up to 1 year post subject's death. ]
    Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.


Secondary Outcome Measures :
  1. Number of Blinded Visual PET Image Interpretations [ Time Frame: Brain images will be assessed up to 1 year post subject's death. ]
    Specificity of blinded visual image interpretations according to neuropathological criteria.

  2. Specificity Percentage of Blinded Visual PET Image Interpretations [ Time Frame: Brain images will be assessed up to 1 year post subject's death. ]
    Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.


Biospecimen Retention:   Samples Without DNA
Brain specimen retained. Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE067-007.
Criteria

Inclusion Criteria:

  • The subject was enrolled in prior Study GE067-007.
  • The subject died on or before 10 June 2013.
  • The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis.

Exclusion Criteria:

  • Not Applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090855


Locations
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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Covance
H2O Clinical LLC
Investigators
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Study Director: Paul Sherwin, M.D. GE Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02090855    
Other Study ID Numbers: GE-067-026
First Posted: March 18, 2014    Key Record Dates
Results First Posted: August 27, 2014
Last Update Posted: March 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Plaque, Amyloid
Pathological Conditions, Anatomical