Traumatic Brain Injury (TBI)Phase 1/2NCT01547780
Translocator Protein and Inflammation After Traumatic Brain Injury
A Phase 1/2 study testing [11C]PBR28 and Positron Emission Tomography (PET) in people with Traumatic Brain Injury (TBI) and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI), Healthy
- What is being tested?
- [11C]PBR28 and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2012to 28 Sep 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects with TBI for both groups 1 and 2 are not eligible for participation in this research study if any of the following conditions exist:
- Present or past history of brain disease other than TBI.
- Subjects with abnormal MRI findings that suggest a diagnosis other than TBI or a second lesion such as brain tumor in addition to the changes consistent with TBI.
- Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. The Medical Advisory Investigator of this protocol will determine whether the subject needs to be excluded.
- Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject's body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject's eyes).
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
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- In female subjects, pregnancy or breastfeeding.
- Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
- HEALTHY SUBJECTS ARE NOT ELIGIBLE FOR PARTICIPATION IN THIS RESEARCH IF ANY OF THE FOLLOWING CONDITIONS EXIST:
- Any past or present history of DSM Axis I disorder, with the exception of substance abuse that ended over 6 months prior to enrollment.
- Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject's body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject's eyes).
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- In female subjects, pregnancy or breastfeeding.
- Clinically significant laboratory abnormalities, as defined as laboratory values that are out of normal range or require clinical workup and/or treatment.
- Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
- Previously determined as a low-affinity binder in another study on TSPO.
- Positive results of urine drug screen on enrollment.
- HIV positive subjects are considered healthy as long as he/she does not show neurological or psychiatric symptoms based on history and physical exams. Results of HIV test in both TBI subjects and healthy controls may help interpretation of the PET results. Statistical analysis: Analysis of date/study outcomes. Results of urine drug screen and history of using drugs of abuse may also help interpretation of the PET results. In addition, inclusion of TBI subjects who show positive for urine drug screen may improve recruitment of TBI subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury
Background:
- People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI.
Read more
Objectives:
- To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury.
Eligibility:
- Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.
- Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation
Read the detailed description
Objective:
Brain damage following traumatic injury (TBI) results from both direct (e.g., mechanical injury to the brain and vasculature) and indirect mechanisms (e.g., secondary mechanisms such as inflammation). While CT and MRI can help visualize the result of inflammatory processes in the brain for instance, the development of cerebral edema neither method can be used to document active inflammation itself. The translocator protein (TSPO), which is highly expressed in microglia and reactive astrocytes, has been used as a biomarker in positron emission tomography (PET) to identify active inflammatory processes. Recently, our laboratory developed PBR28, a new PET ligand that images TSPO with high levels of specific binding. We have successfully used PBR28 to investigate a number of brain disorders such as epilepsy, multiple sclerosis, and HIV infection with minor cognitive motor disorder, and are detecting neuroinflammation. The current protocol aims to explore whether PBR28 PET imaging can show changes in subjects with TBI who have shown MRI abnormalities in the acute phase and also in those who are in the chronic phase of TBI.
Study population: The following three groups will be studied:
TBI subjects who had brain injury within approximately 3 months and have exhibited MRI abnormalities consistent with TBI and who are enrolled in "Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury" (10-N-N122, PI Latour), "Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI), (11-N-0084, PI: Lawrence Latour), or other CNRM protocols. N = 20
TBI subjects who had brain injury more than approximately 5 month ago, are enrolled in 11-N-0084, and meet criteria of TBI established by CNRM. N = 20
Healthy age-matched volunteers. N = 20.
Design:
This is an exploratory study to determine whether PBR28 can detect the increased TSPO associated with neuroinflammation by scanning subjects who have shown MRI abnormalities in the acute phase. We also investigate whether PBR28 detects changes in the chronic phase as recently reported using an old ligand, PK 11195. Two groups of TBI subjects will be studied depending on their availability relative to the time of injury. To investigate changes in TSPO in the areas of MRI abnormalities in the acute phase, one group of TBI subjects (n = 20) will be studied who have shown TBI- related MRI abnormalities. These participants will have up to four PBR28 PET scans; one to two PET scans within approximately 10 days of head injury, a third PET scan approximately three months after injury, and a fourth scan approximately one year after the scan at ~three months. To study changes in TSPO in the chronic phase, another group of TBI subjects will be enrolled who had brain injury more than approximately 5 months but within 5 years ago and meet the criteria of TBI by CNRM. This separate group is included because some TBI subjects are being recruited by CNRM only sometime after the injury. The participants at the chronic phase will have one PET and one MRI scan. In addition to MRI data, for all TBI subjects, clinical information obtained in 10-N-N122 (only the acute phase) and 11-N-0084 (both acute and chronic phase) will be used to evaluate the utility of the PET data in order to better understand the pathology of TBI.
Outcome Measures:
In this exploratory study to investigate the ability of PBR28 PET to detect increases in TSPO, the primary goal will be to measure the magnitude and variance of any increases observed in PBR28 binding in areas of inflammation following TBI. Those data may be used to design future studies with a larger sample size.
- Conditions
- Traumatic Brain Injury (TBI), Healthy
- Being tested
- [11C]PBR28 and Positron Emission Tomography (PET)
- Keywords
- Positron Emission Tomography (PET), Inflammation, Microglial Activation, Traumatic Brain Injury, TBI
- Medical subject headings
- Brain Injuries, Traumatic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]PBR28 and Positron Emission Tomography (PET)Drug
Brain PET with [11C]PBR28. 11C]PBR28 is a new PET ligand that images TSPO with high levels of specific binding.
| Study group | Role | What they receive |
|---|---|---|
| Baseline brain PET in acute TBI patient | Experimental | 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. Receives: Drug: [11C]PBR28 and Positron Emission Tomography (PET) |
| Repeat brain PET in acute TBI patient | Experimental | 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. Receives: Drug: [11C]PBR28 and Positron Emission Tomography (PET) |
| Single brain PET in Chronic TBI patient | Experimental | 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. Receives: Drug: [11C]PBR28 and Positron Emission Tomography (PET) |
| Single brain PET in healthy subjects | Experimental | Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects. Receives: Drug: [11C]PBR28 and Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor Binding (Vt)
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).
Measured: 120 minutes from the start of the PET scan
Receptor Binding Corrected for Plasma (Vt/fp)
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).
Measured: 120 minutes from the start of the PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study start20 Jan 2012
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Suburban Hospital, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Robert Innis, MD, PhD, Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547780
- Sponsor's protocol ID
- 120063
- Other IDs
- 12-M-0063
- Status last verified
- 28 Sep 2017
- First submitted
- 6 Mar 2012
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Brown AK, Fujita M, Fujimura Y, Liow JS, Stabin M, Ryu YH, Imaizumi M, Hong J, Pike VW, Innis RB. Radiation dosimetry and biodistribution in monkey and man of 11C-PBR28: a PET radioligand to image inflammation. J Nucl Med. 2007 Dec;48(12):2072-9. doi: 10.2967/jnumed.107.044842. Epub 2007 Nov 15.
PubMed 18006619Cernak I, O'Connor C, Vink R. Activation of cyclo-oxygenase-2 contributes to motor and cognitive dysfunction following diffuse traumatic brain injury in rats. Clin Exp Pharmacol Physiol. 2001 Nov;28(11):922-5. doi: 10.1046/j.1440-1681.2001.03549.x.
PubMed 11703397Conzen M, Ebel H, Swart E, Skreczek W, Dette M, Oppel F. Long-term neuropsychological outcome after severe head injury with good recovery. Brain Inj. 1992 Jan-Feb;6(1):45-52. doi: 10.3109/02699059209008121.
PubMed 1739852Paul S, Gallagher E, Liow JS, Mabins S, Henry K, Zoghbi SS, Gunn RN, Kreisl WC, Richards EM, Zanotti-Fregonara P, Morse CL, Hong J, Kowalski A, Pike VW, Innis RB, Fujita M. Building a database for brain 18 kDa translocator protein imaged using [11C]PBR28 in healthy subjects. J Cereb Blood Flow Metab. 2019 Jun;39(6):1138-1147. doi: 10.1177/0271678X18771250. Epub 2018 May 11.
PubMed 29749279
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01547780
- Acronym / sponsor ID
- 120063
- Conditions
- Traumatic Brain Injury (TBI), Healthy
- Keywords
- Positron Emission Tomography (PET), Inflammation, Microglial Activation, Traumatic Brain Injury, TBI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Collaborators
- Suburban Hospital, Uniformed Services University of the Health Sciences
- Study start
- 20 Jan 2012
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI.
Objectives:
- To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury.
Eligibility:
- Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.
- Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation
Detailed description
Objective:
Brain damage following traumatic injury (TBI) results from both direct (e.g., mechanical injury to the brain and vasculature) and indirect mechanisms (e.g., secondary mechanisms such as inflammation). While CT and MRI can help visualize the result of inflammatory processes in the brain for instance, the development of cerebral edema neither method can be used to document active inflammation itself. The translocator protein (TSPO), which is highly expressed in microglia and reactive astrocytes, has been used as a biomarker in positron emission tomography (PET) to identify active inflammatory processes. Recently, our laboratory developed PBR28, a new PET ligand that images TSPO with high levels of specific binding. We have successfully used PBR28 to investigate a number of brain disorders such as epilepsy, multiple sclerosis, and HIV infection with minor cognitive motor disorder, and are detecting neuroinflammation. The current protocol aims to explore whether PBR28 PET imaging can show changes in subjects with TBI who have shown MRI abnormalities in the acute phase and also in those who are in the chronic phase of TBI.
Study population: The following three groups will be studied:
TBI subjects who had brain injury within approximately 3 months and have exhibited MRI abnormalities consistent with TBI and who are enrolled in "Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury" (10-N-N122, PI Latour), "Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI), (11-N-0084, PI: Lawrence Latour), or other CNRM protocols. N = 20
TBI subjects who had brain injury more than approximately 5 month ago, are enrolled in 11-N-0084, and meet criteria of TBI established by CNRM. N = 20
Healthy age-matched volunteers. N = 20.
Design:
This is an exploratory study to determine whether PBR28 can detect the increased TSPO associated with neuroinflammation by scanning subjects who have shown MRI abnormalities in the acute phase. We also investigate whether PBR28 detects changes in the chronic phase as recently reported using an old ligand, PK 11195. Two groups of TBI subjects will be studied depending on their availability relative to the time of injury. To investigate changes in TSPO in the areas of MRI abnormalities in the acute phase, one group of TBI subjects (n = 20) will be studied who have shown TBI- related MRI abnormalities. These participants will have up to four PBR28 PET scans; one to two PET scans within approximately 10 days of head injury, a third PET scan approximately three months after injury, and a fourth scan approximately one year after the scan at ~three months. To study changes in TSPO in the chronic phase, another group of TBI subjects will be enrolled who had brain injury more than approximately 5 months but within 5 years ago and meet the criteria of TBI by CNRM. This separate group is included because some TBI subjects are being recruited by CNRM only sometime after the injury. The participants at the chronic phase will have one PET and one MRI scan. In addition to MRI data, for all TBI subjects, clinical information obtained in 10-N-N122 (only the acute phase) and 11-N-0084 (both acute and chronic phase) will be used to evaluate the utility of the PET data in order to better understand the pathology of TBI.
Outcome Measures:
In this exploratory study to investigate the ability of PBR28 PET to detect increases in TSPO, the primary goal will be to measure the magnitude and variance of any increases observed in PBR28 binding in areas of inflammation following TBI. Those data may be used to design future studies with a larger sample size.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline brain PET in acute TBI patient | Experimental | Drug: [11C]PBR28 and Positron Emission Tomography (PET)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. |
| Repeat brain PET in acute TBI patient | Experimental | Drug: [11C]PBR28 and Positron Emission Tomography (PET)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 | Experimental | Drug: [11C]PBR28 and Positron Emission Tomography (PET)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 | Experimental | Drug: [11C]PBR28 and Positron Emission Tomography (PET)Single intravenous injection of [C-11]PBR28, ~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Subjects with TBI for both groups 1 and 2 are not eligible for participation in this research study if any of the following conditions exist:
- Present or past history of brain disease other than TBI.
- Subjects with abnormal MRI findings that suggest a diagnosis other than TBI or a second lesion such as brain tumor in addition to the changes consistent with TBI.
- Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. The Medical Advisory Investigator of this protocol will determine whether the subject needs to be excluded.
- Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a subject's body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the subject's eyes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]PBR28 and Positron Emission Tomography (PET)Brain PET with [11C]PBR28. 11C]PBR28 is a new PET ligand that images TSPO with high levels of specific binding. | Drug | Baseline brain PET in acute TBI patient, Repeat brain PET in acute TBI patient, Single brain PET in Chronic TBI patient, Single brain PET in healthy subjects |
Primary outcome
Receptor Binding (Vt)
Time frame: 120 minutes from the start of the 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).
Receptor Binding Corrected for Plasma (Vt/fp)
Time frame: 120 minutes from the start of the 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18006619Brown AK, Fujita M, Fujimura Y, Liow JS, Stabin M, Ryu YH, Imaizumi M, Hong J, Pike VW, Innis RB. Radiation dosimetry and biodistribution in monkey and man of 11C-PBR28: a PET radioligand to image inflammation. J Nucl Med. 2007 Dec;48(12):2072-9. doi: 10.2967/jnumed.107.044842. Epub 2007 Nov 15.
- Background: PubMed 11703397Cernak I, O'Connor C, Vink R. Activation of cyclo-oxygenase-2 contributes to motor and cognitive dysfunction following diffuse traumatic brain injury in rats. Clin Exp Pharmacol Physiol. 2001 Nov;28(11):922-5. doi: 10.1046/j.1440-1681.2001.03549.x.
- Background: PubMed 1739852Conzen M, Ebel H, Swart E, Skreczek W, Dette M, Oppel F. Long-term neuropsychological outcome after severe head injury with good recovery. Brain Inj. 1992 Jan-Feb;6(1):45-52. doi: 10.3109/02699059209008121.
- Derived from this study: PubMed 29749279Paul S, Gallagher E, Liow JS, Mabins S, Henry K, Zoghbi SS, Gunn RN, Kreisl WC, Richards EM, Zanotti-Fregonara P, Morse CL, Hong J, Kowalski A, Pike VW, Innis RB, Fujita M. Building a database for brain 18 kDa translocator protein imaged using [11C]PBR28 in healthy subjects. J Cereb Blood Flow Metab. 2019 Jun;39(6):1138-1147. doi: 10.1177/0271678X18771250. Epub 2018 May 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Innis, MD, PhD principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [11C]PBR28 and Positron Emission Tomography (PET) in people with Traumatic Brain Injury (TBI) and Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receptor Binding (Vt) (time frame: 120 minutes from the start of the PET scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547780, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.