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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01564706
Enrollment
9
Registered
2012-03-28
Start date
2007-10-31
Completion date
2008-01-31
Last updated
2012-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

Brief summary

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

Interventions

DRUGflorbetapir F 18

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

Sponsors

Avid Radiopharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Whole Body Radiation Dosimetry0-380 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Healthy Volunteers
Single i.v. administration of approximately 10mCi 18F-AV-45
9
Total9

Baseline characteristics

CharacteristicHealthy Volunteers
Age Continuous57.9 years
STANDARD_DEVIATION 10.31
Race/Ethnicity, Customized
Black
1 participants
Race/Ethnicity, Customized
Caucasian
8 participants
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
5 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

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.

Time frame: 0-380 min after injection

ArmMeasureGroupValue (MEAN)Dispersion
Healthy VolunteersWhole Body Radiation DosimetryThymus0.00727 mSv/MBqStandard Deviation 0.00122
Healthy VolunteersWhole Body Radiation DosimetryThyroid0.00675 mSv/MBqStandard Deviation 0.00143
Healthy VolunteersWhole Body Radiation DosimetryUrinary Bladder Wall0.0271 mSv/MBqStandard Deviation 0.0117
Healthy VolunteersWhole Body Radiation DosimetryUterus0.0156 mSv/MBqStandard Deviation 0.00319
Healthy VolunteersWhole Body Radiation DosimetryTotal Body0.0116 mSv/MBqStandard Deviation 0.000951
Healthy VolunteersWhole Body Radiation DosimetryEffective Dose0.0186 mSv/MBqStandard Deviation 0.00426
Healthy VolunteersWhole Body Radiation DosimetryAdrenals0.0136 mSv/MBqStandard Deviation 0.00129
Healthy VolunteersWhole Body Radiation DosimetryBrain0.01 mSv/MBqStandard Deviation 0.00186
Healthy VolunteersWhole Body Radiation DosimetryBreasts0.00624 mSv/MBqStandard Deviation 0.000865
Healthy VolunteersWhole Body Radiation DosimetryGallbladder Wall0.143 mSv/MBqStandard Deviation 0.0802
Healthy VolunteersWhole Body Radiation DosimetryLower Large Intestine Wall0.0278 mSv/MBqStandard Deviation 0.0102
Healthy VolunteersWhole Body Radiation DosimetrySmall Intestine0.0655 mSv/MBqStandard Deviation 0.0296
Healthy VolunteersWhole Body Radiation DosimetryStomach Wall0.0117 mSv/MBqStandard Deviation 0.000906
Healthy VolunteersWhole Body Radiation DosimetryUpper Large Intestine Wall0.0745 mSv/MBqStandard Deviation 0.0342
Healthy VolunteersWhole Body Radiation DosimetryHeart Wall0.0131 mSv/MBqStandard Deviation 0.00159
Healthy VolunteersWhole Body Radiation DosimetryKidneys0.013 mSv/MBqStandard Deviation 0.00111
Healthy VolunteersWhole Body Radiation DosimetryLiver0.0644 mSv/MBqStandard Deviation 0.0221
Healthy VolunteersWhole Body Radiation DosimetryLungs0.00852 mSv/MBqStandard Deviation 0.000801
Healthy VolunteersWhole Body Radiation DosimetryMuscle0.00863 mSv/MBqStandard Deviation 0.000762
Healthy VolunteersWhole Body Radiation DosimetryOvaries0.0176 mSv/MBqStandard Deviation 0.00434
Healthy VolunteersWhole Body Radiation DosimetryPancreas0.0144 mSv/MBqStandard Deviation 0.00134
Healthy VolunteersWhole Body Radiation DosimetryRed Marrow0.0143 mSv/MBqStandard Deviation 0.00178
Healthy VolunteersWhole Body Radiation DosimetryOsteogenic Cells0.0276 mSv/MBqStandard Deviation 0.00371
Healthy VolunteersWhole Body Radiation DosimetrySkin0.00593 mSv/MBqStandard Deviation 0.000809
Healthy VolunteersWhole Body Radiation DosimetrySpleen0.0089 mSv/MBqStandard Deviation 0.000986
Healthy VolunteersWhole Body Radiation DosimetryTestes0.00681 mSv/MBqStandard Deviation 0.00129

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026