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

GE Healthcare203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

203

Conditions

Brain Fibrillarab Levels

Interventions

[18F] FlutemetamolDRUG

Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator. * The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. * The subject's general health is adequate to undergo the study procedures. Exclusion Criteria: * The subject has a contraindication for PET. * The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients. * The subject is unable to tolerate or cooperate with study procedures.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.

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.

Time frame: Post flutemetamol administration.

Secondary Outcomes

Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.

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.

Time frame: Post Flutemetamol administrations

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 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 Normal, 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.