Trial Outcomes & Findings for Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images (NCT NCT01672827)

Last Updated: 2014-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

276 participants

Primary outcome timeframe

Post flutemetamol administration

Results posted on

2014-01-24

Participant Flow

This study examined brain PET scans from 276 subjects previously acquired form various GE Healthcare studies (GE-067. The study did not enroll the blinded image Readers.

Participant milestones

Participant milestones
Measure	[18F]Flutemetamol No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
Overall Study STARTED	276
Overall Study COMPLETED	276
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	[18F]Flutemetamol n=276 Participants No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants
Age, Categorical >=65 years	195 Participants n=5 Participants
Age, Continuous	68.2 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants
Sex: Female, Male Male	140 Participants n=5 Participants
Region of Enrollment United States	118 participants n=5 Participants
Region of Enrollment Belgium	66 participants n=5 Participants
Region of Enrollment Denmark	12 participants n=5 Participants
Region of Enrollment Finland	37 participants n=5 Participants
Region of Enrollment Japan	16 participants n=5 Participants
Region of Enrollment Sweden	3 participants n=5 Participants
Region of Enrollment United Kingdom	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Post flutemetamol administration

Population: Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).

Outcome measures

Outcome measures
Measure	Sensitivity % n=51 Participants Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 1	94 Percentage (True Positive) Interval 84.0 to 99.0
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 2	92 Percentage (True Positive) Interval 81.0 to 98.0
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 3	90 Percentage (True Positive) Interval 79.0 to 97.0
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 4	94 Percentage (True Positive) Interval 84.0 to 99.0
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 5	84 Percentage (True Positive) Interval 71.0 to 93.0
Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. Majority Read	94 Percentage (True Positive) Interval 84.0 to 99.0

PRIMARY outcome

Timeframe: Post flutemetamol administration

Population: Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).

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.

Outcome measures

Outcome measures
Measure	Sensitivity % n=84 Participants Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 3	93 Percentage (True Negative) Interval 85.0 to 97.0
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 4	77 Percentage (True Negative) Interval 67.0 to 86.0
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 5	96 Percentage (True Negative) Interval 90.0 to 99.0
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Majority Read	92 Percentage (True Negative) Interval 84.0 to 97.0
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 1	79 Percentage (True Negative) Interval 68.0 to 87.0
Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. Reader 2	81 Percentage (True Negative) Interval 71.0 to 89.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sensitivity % n=276 Participants Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 1 vs Reader 2	248 Number of inter-reader agreements Interval 73.0 to 87.0
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 1 vs Reader 3	257 Number of inter-reader agreements Interval 0.8 to 0.92
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 1 vs Reader 4	242 Number of inter-reader agreements Interval 0.68 to 0.83
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 1 vs Reader 5	251 Number of inter-reader agreements Interval 0.75 to 0.89
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 2 vs Reader 3	255 Number of inter-reader agreements Interval 0.79 to 0.91
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 2 vs Reader 4	250 Number of inter-reader agreements Interval 0.74 to 0.88
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 2 vs Reader 5	251 Number of inter-reader agreements Interval 0.75 to 0.89
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 3 vs Reader 4	253 Number of inter-reader agreements Interval 0.77 to 0.9
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 3 vs Reader 5	268 Number of inter-reader agreements Interval 0.9 to 0.98
Inter-Reader Agreement of PET Images Without Anatomic Images Reader 4 vs Reader 5	245 Number of inter-reader agreements Interval 0.71 to 0.85
Inter-Reader Agreement of PET Images Without Anatomic Images Readers 1,2,3,4,5	223 Number of inter-reader agreements Interval 0.79 to 0.86

Adverse Events

[18F]Flutemetamol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Sherwin, M.D.

GE Healthcare

Phone: 1-609-514-6820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place