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NCT02090855 · ClinicalTrials.gov registry record

Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

A clinical trial, sponsored by GE Healthcare.

Completed
Registry status
108
Enrollment target

NCT02090855: Completed study, sponsored by GE Healthcare.

NCT02090855 is a clinical trial that has completed, run by GE Healthcare. The registered enrollment target is 108 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02090855 has completed, sponsored by GE Healthcare.

COMPLETED
Registry status
108 participants
Enrollment target

Study Summary

Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.

Primary Outcome

Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of \[18F\]flutemetamol PET images through an electronic training program.

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2013-09
Est. Completion 2014-02
GE Healthcare

99 total trials

What the finished NCT02090855 record still lists

NCT02090855 is an observational study that tracks outcomes without assigning an intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT02090855 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02090855 about?

NCT02090855 is a clinical study titled "Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem". Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent reader...

What is the current status of trial NCT02090855?

This trial is currently completed. The enrollment target is 108 participants. The study started on 2013-09. Estimated completion is 2014-02.

Who is sponsoring clinical trial NCT02090855?

This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02090855, the US trial registry maintained by the National Library of Medicine. NCT02090855 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.