Trial Outcomes & Findings for Evaluation of Physician Training Methods to Read Florbetapir-PET Scans (NCT NCT01565369)

Results Overview

Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

50-60 min after injection

Results posted on

2012-06-07

Participant Flow

NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies

Participant milestones

Participant milestones
Measure	All A07 Autopsy Subjects Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Physician Training Methods to Read Florbetapir-PET Scans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All A07 Autopsy Subjects n=35 Participants Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
Age Continuous	79.3 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 50-60 min after injection

Population: 19 of the 35 subjects had moderate or frequent plaques at autopsy

Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.

Outcome measures

Outcome measures
Measure	All A07(NCT00857415) Autopsy Subjects n=19 Participants Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque	100 percentage of true positives Interval 84.2 to 100.0

PRIMARY outcome

Timeframe: 50-60 min after injection

Population: 16 of the 35 subjects had none or sparse plaques at autopsy

Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.

Outcome measures

Outcome measures
Measure	All A07(NCT00857415) Autopsy Subjects n=16 Participants Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque	93.8 percentage of true negatives Interval 68.8 to 100.0

SECONDARY outcome

Timeframe: 50-60 min after injection

Population: 315 scans = 35 subjects x 9 readers

Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers

Outcome measures

Outcome measures
Measure	All A07(NCT00857415) Autopsy Subjects n=315 florbetapir PET scan reads Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
Inter-reader Agreement Agreed with majority read	96.2 percentage of scans
Inter-reader Agreement Discrepant with majority read	3.8 percentage of scans

Adverse Events

All A07 Autopsy Subjects

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

Chief Medical Officer

Avid Radiopharmaceuticals

Phone: 215-798-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60