Clinical Trial: Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem

Brief Summary: To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Detailed Summary:
Sponsor: GE Healthcare

Current Primary Outcome: The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. [ Time Frame: Post flutemetamol administration. ]

A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants).

Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.



Original Primary Outcome: Comparison of brain amyloid deposits taken from brain samples analyzed post-mortem to prior brain images made with [18F]flutemetamol. [ Time Frame: Time zero equals the date of PET imaging. After imaging, each subject will undergo follow-up until either death or study termination, whichever occurs first within a 1 year timeframe. ]

To test if brain images made with [18F]flutemetamol product can safely predict which subjects have brain amyloid deposits when brain samples are analyzed post-mortem.


Current Secondary Outcome:

  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. [ Time Frame: Post Flutemetamol administrations ]

    A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants).

    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.

  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. [ Time Frame: Post flutemetamol administration. ]
    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.
  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. [ Time Frame: Post flutemetamol administration. ]
    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.


Original Secondary Outcome: Level of association between quantitative regional estimates of brain uptake of F18 flutemetamol from analysis of PET and quantitative histochemical regional estimates of brain levels of amyloid from post-mortem analysis of corresponding brain tissue [ Time Frame: Time zero equals the date of PET imaging. After imaging, each subject will undergo follow-up until either death or study termination, whichever occurs first within a 1 year timeframe. ]

To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol (from analysis of PET images) and quantitative histochemical regional estimates of brain levels of amyloid from post-mortem analysis of corresponding brain tissue samples. The quantitative estimates of brain uptake of [18F]flutemetamol SUVR will be compared to prior brain images made with [18F]flutemetamol.


Information By: GE Healthcare

Dates:
Date Received: June 21, 2010
Date Started: May 2010
Date Completion:
Last Updated: November 8, 2013
Last Verified: November 2013