Trial Outcomes & Findings for A Study of 18F-AV-45 in Healthy Volunteers (NCT NCT01564706)
NCT ID: NCT01564706
Last Updated: 2012-05-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
0-380 min after injection
Results posted on
2012-05-18
Participant Flow
Participant milestones
| Measure |
Healthy Volunteers
Single i.v. administration of approximately 10mCi 18F-AV-45
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of 18F-AV-45 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=9 Participants
Single i.v. administration of approximately 10mCi 18F-AV-45
|
|---|---|
|
Age Continuous
|
57.9 years
STANDARD_DEVIATION 10.31 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-380 min after injectionRadiation 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.
Outcome measures
| Measure |
Healthy Volunteers
n=9 Participants
Single i.v. administration of approximately 10mCi 18F-AV-45
|
|---|---|
|
Whole Body Radiation Dosimetry
Kidneys
|
0.013 mSv/MBq
Standard Deviation 0.00111
|
|
Whole Body Radiation Dosimetry
Liver
|
0.0644 mSv/MBq
Standard Deviation 0.0221
|
|
Whole Body Radiation Dosimetry
Effective Dose
|
0.0186 mSv/MBq
Standard Deviation 0.00426
|
|
Whole Body Radiation Dosimetry
Adrenals
|
0.0136 mSv/MBq
Standard Deviation 0.00129
|
|
Whole Body Radiation Dosimetry
Brain
|
0.01 mSv/MBq
Standard Deviation 0.00186
|
|
Whole Body Radiation Dosimetry
Breasts
|
0.00624 mSv/MBq
Standard Deviation 0.000865
|
|
Whole Body Radiation Dosimetry
Gallbladder Wall
|
0.143 mSv/MBq
Standard Deviation 0.0802
|
|
Whole Body Radiation Dosimetry
Lower Large Intestine Wall
|
0.0278 mSv/MBq
Standard Deviation 0.0102
|
|
Whole Body Radiation Dosimetry
Small Intestine
|
0.0655 mSv/MBq
Standard Deviation 0.0296
|
|
Whole Body Radiation Dosimetry
Stomach Wall
|
0.0117 mSv/MBq
Standard Deviation 0.000906
|
|
Whole Body Radiation Dosimetry
Upper Large Intestine Wall
|
0.0745 mSv/MBq
Standard Deviation 0.0342
|
|
Whole Body Radiation Dosimetry
Heart Wall
|
0.0131 mSv/MBq
Standard Deviation 0.00159
|
|
Whole Body Radiation Dosimetry
Lungs
|
0.00852 mSv/MBq
Standard Deviation 0.000801
|
|
Whole Body Radiation Dosimetry
Muscle
|
0.00863 mSv/MBq
Standard Deviation 0.000762
|
|
Whole Body Radiation Dosimetry
Ovaries
|
0.0176 mSv/MBq
Standard Deviation 0.00434
|
|
Whole Body Radiation Dosimetry
Pancreas
|
0.0144 mSv/MBq
Standard Deviation 0.00134
|
|
Whole Body Radiation Dosimetry
Red Marrow
|
0.0143 mSv/MBq
Standard Deviation 0.00178
|
|
Whole Body Radiation Dosimetry
Osteogenic Cells
|
0.0276 mSv/MBq
Standard Deviation 0.00371
|
|
Whole Body Radiation Dosimetry
Skin
|
0.00593 mSv/MBq
Standard Deviation 0.000809
|
|
Whole Body Radiation Dosimetry
Spleen
|
0.0089 mSv/MBq
Standard Deviation 0.000986
|
|
Whole Body Radiation Dosimetry
Testes
|
0.00681 mSv/MBq
Standard Deviation 0.00129
|
|
Whole Body Radiation Dosimetry
Thymus
|
0.00727 mSv/MBq
Standard Deviation 0.00122
|
|
Whole Body Radiation Dosimetry
Thyroid
|
0.00675 mSv/MBq
Standard Deviation 0.00143
|
|
Whole Body Radiation Dosimetry
Urinary Bladder Wall
|
0.0271 mSv/MBq
Standard Deviation 0.0117
|
|
Whole Body Radiation Dosimetry
Uterus
|
0.0156 mSv/MBq
Standard Deviation 0.00319
|
|
Whole Body Radiation Dosimetry
Total Body
|
0.0116 mSv/MBq
Standard Deviation 0.000951
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers
n=9 participants at risk
Single i.v. administration of approximately 10mCi 18F-AV-45
|
|---|---|
|
Cardiac disorders
PALPITATIONS
|
11.1%
1/9 • Number of events 1 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
|
Gastrointestinal disorders
NAUSEA
|
22.2%
2/9 • Number of events 2 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
|
General disorders
CHEST PAIN
|
11.1%
1/9 • Number of events 1 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.1%
1/9 • Number of events 1 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
33.3%
3/9 • Number of events 3 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
|
Psychiatric disorders
ANXIETY
|
11.1%
1/9 • Number of events 1 • AEs occuring within 3 days of injection; SAEs occuring within 30 days of injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60