A Study of 18F-AV-45 in Healthy Volunteers

This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

Completed

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Jenkintown, Pennsylvania, 19406, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to lie still on the imaging table for periods up to 1 hour

Exclusion criteria

Radiation exposure for experimental purposes within the last year
Claustrophobic or otherwise unable to tolerate the imaging procedure
Medical condition or surgical history that would confound evaluation
Current clinically significant cardiovascular disease
Received an investigational medication within the last 30 days

Treatment and study plan

florbetapir F 18

Drug

IV injection, 370MBq (10mCi), single dose

Other names: 18F-AV-45, Amyvid, florbetapir

Primary outcomes

Whole Body Radiation Dosimetry

Time frame: 0-380 min after injection

Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Mar 28, 2012
Registry last updated: May 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed