Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

Phase 3

Completed

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Drug: [18F]Flutemetamol

• Registration Number: NCT01672827
• Lead Sponsor: GE Healthcare

Brief Summary

To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting \[18F\]flutemetamol Positron Emission Tomography (PET) Images.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-27
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2013-10-24
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Results First Posted: 2013-12-19
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.

• The subject was classified as one of the following:

  1. End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
  2. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
  3. Elderly healthy volunteer (age ≥55).
  4. Young healthy volunteer (age ≤40).
  5. Subject with probable Alzheimer Disease (pAD).
  6. Subject with amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria

• Not Applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]Flutemetamol	[18F]Flutemetamol	-

Primary Outcome Measures

Name	Time	Method
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.	Post flutemetamol administration	Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.	Post flutemetamol administration	Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.

Secondary Outcome Measures

Name	Time	Method
Inter-Reader Agreement of PET Images Without Anatomic Images	Post Flutemetamol Injection	Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.