Trial Outcomes & Findings for Translocator Protein and Inflammation After Traumatic Brain Injury (NCT NCT01547780)
NCT ID: NCT01547780
Last Updated: 2021-07-30
Results Overview
To determine total distribution volume of \[C-11\]PBR28 in the whole brain using PET and arterial input function (concentration of radioligand in arterial plasma over time).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
120 minutes from the start of the PET scan
Results posted on
2021-07-30
Participant Flow
52 subjects were consented but two subjects withdrew after consent/lost to follow up.
Participant milestones
| Measure |
Baseline Brain PET in Acute TBI Patient
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Repeat Brain PET in Acute TBI Patient
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Chronic TBI Patient
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Healthy Subjects
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
|
|---|---|---|---|---|
|
Baseline PET Scan
STARTED
|
12
|
0
|
19
|
19
|
|
Baseline PET Scan
COMPLETED
|
9
|
0
|
17
|
19
|
|
Baseline PET Scan
NOT COMPLETED
|
3
|
0
|
2
|
0
|
|
Repeat PET Scan
STARTED
|
0
|
4
|
0
|
0
|
|
Repeat PET Scan
COMPLETED
|
0
|
4
|
0
|
0
|
|
Repeat PET Scan
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Baseline Brain PET in Acute TBI Patient
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Repeat Brain PET in Acute TBI Patient
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Chronic TBI Patient
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Healthy Subjects
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
|
|---|---|---|---|---|
|
Baseline PET Scan
Physician Decision
|
1
|
0
|
1
|
0
|
|
Baseline PET Scan
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
Baseline Characteristics
Translocator Protein and Inflammation After Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Baseline Brain PET in Acute TBI Patient
n=12 Participants
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Chronic TBI Patient
n=19 Participants
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Healthy Subjects
n=19 Participants
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 120 minutes from the start of the PET scanPopulation: The analyses only included subjects who completed the brain \[C-11\]PBR28 PET scan
To determine total distribution volume of \[C-11\]PBR28 in the whole brain using PET and arterial input function (concentration of radioligand in arterial plasma over time).
Outcome measures
| Measure |
Baseline Brain PET in Acute TBI Patient
n=7 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Repeat Brain PET in Acute TBI Patient
n=3 Participants
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Chronic TBI Patient
n=16 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Healthy Subjects
n=16 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
|
|---|---|---|---|---|
|
Receptor Binding (Vt)
|
2.53 mL/cm^3
Standard Deviation 0.50
|
2.21 mL/cm^3
Standard Deviation 0.49
|
3.21 mL/cm^3
Standard Deviation 1.04
|
3.22 mL/cm^3
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: 120 minutes from the start of the PET scanPopulation: The analyses only included subjects who completed the brain \[C-11\]PBR28 PET scan
Total distribution volume divided by plasma free fraction (fp) of \[C-11\]PBR28. Measured with PET and arterial input function (concentration of radioligand in arterial plasma over time).
Outcome measures
| Measure |
Baseline Brain PET in Acute TBI Patient
n=7 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Repeat Brain PET in Acute TBI Patient
n=3 Participants
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Chronic TBI Patient
n=16 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
|
Single Brain PET in Healthy Subjects
n=16 Participants
One \~10-20 mCi intravenous injection of \[C-11\]PBR28 prior to brain positron emission tomography (PET) scan in Healthy Subjects.
|
|---|---|---|---|---|
|
Receptor Binding Corrected for Plasma (Vt/fp)
|
93.72 mL/cm^3
Standard Deviation 20.83
|
80.32 mL/cm^3
Standard Deviation 10.35
|
118.73 mL/cm^3
Standard Deviation 37.98
|
103.99 mL/cm^3
Standard Deviation 29.52
|
Adverse Events
Baseline Brain PET in Acute TBI Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Repeat Brain PET in Acute TBI Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Brain PET in Chronic TBI Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Brain PET in Healthy Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place