A Study of 18F-AV-45 in Healthy Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: March 25, 2012
Last updated: May 11, 2012
Last verified: May 2012
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Avid Radiopharmaceuticals:
Primary Outcome Measures:
- Whole Body Radiation Dosimetry [ Time Frame: 0-380 min after injection ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: Healthy Volunteers
Healthy male or female subjects, between 18 and 85 years of age.
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564706
|United States, Pennsylvania|
|Jenkintown, Pennsylvania, United States, 19406|
Sponsors and Collaborators
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals|