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

Mild Cognitive Impairment Clinical Trial

Official title:

A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672827
• Other study ID #: GE-067-021
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2012
• Last updated: December 18, 2013
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• [18F]Flutemetamol
No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.	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.	Post flutemetamol administration	No
Primary	Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.	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.	Post flutemetamol administration	No
Secondary	Inter-Reader Agreement of PET Images Without Anatomic Images	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.	Post Flutemetamol Injection	No