A Study of 18F-AV-45 in Healthy Volunteers
Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45
1 other identifier
interventional
9
1 country
1
Brief Summary
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 alzheimer-disease
Started Oct 2007
Shorter than P25 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 25, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedResults Posted
Study results publicly available
April 30, 2012
CompletedMay 18, 2012
May 1, 2012
3 months
March 25, 2012
April 3, 2012
May 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Whole Body Radiation Dosimetry
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.
0-380 min after injection
Study Arms (1)
Healthy Volunteers
EXPERIMENTALHealthy male or female subjects, between 18 and 85 years of age.
Interventions
IV injection, 370MBq (10mCi), single dose
Eligibility Criteria
You may qualify if:
- Able to lie still on the imaging table for periods up to 1 hour
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site
Jenkintown, Pennsylvania, 19406, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avid Radiopharmaceuticals
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Avid Radiopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2012
First Posted
March 28, 2012
Study Start
October 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 18, 2012
Results First Posted
April 30, 2012
Record last verified: 2012-05