Traumatic Brain InjuryPhase 1NCT02512029
18F-AV-1451 PET Imaging in TBI
A Phase 1 study testing 18F-AV-1451 in people with Traumatic Brain Injury, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial summary
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- 18F-AV-1451
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- TBI Subjects
- Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084
- History of having sustained a TBI < 6 weeks prior to enrollment
- Can tolerate PET and MRI scan procedures
- Control Subjects
- MMSE ≥ 28
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- No significant history of cognitive impairment
- No prior history of TBI
- Can tolerate PET and MRI scan procedures
Who cannot join
- Have behavior dysfunction that is likely to interfere with imaging
- Are claustrophobic or otherwise unable to tolerate the imaging procedure
- Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG
- A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
- Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
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- Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18F-AV-1451 imaging session
- Have current alcohol dependence or alcohol dependence within the past 1 year
- Are currently participating in another interventional clinical trial
- Have evidence of a penetrating brain injury
- Have participated in contact sports in college or after high school age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.
- Conditions
- Traumatic Brain Injury
- Being tested
- 18F-AV-1451
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-1451Drug
Also called [F-18]T807
| Study group | Role | What they receive |
|---|---|---|
| TBI Subjects | Experimental | Subjects with history of recent subacute Traumatic Brain Injury (TBI) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451 2 to 6 weeks following injury. They will return for a follow-up injection approximately 6 months following injury. Receives: Drug: 18F-AV-1451 |
| Control | Experimental | Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451. Receives: Drug: 18F-AV-1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBI Biomarker Analysis
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Measured: 75-105 minutes postinjection
Relationship Between Clinical Presentation and Tau Deposition (MMSE)
The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
Measured: 75-105 minutes postinjection
Change in tau deposition over time
Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.
Measured: 6 months
Relationship Between Clinical Presentation and Tau Deposition (BIS-11)
The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)
Measured: 75-105 minutes postinjection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512029
- Sponsor's protocol ID
- 18F-AV-1451-A12
- Status last verified
- Feb 2016
- First submitted
- 28 Jul 2015
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02512029
- Acronym / sponsor ID
- 18F-AV-1451-A12
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Subjects | Experimental | Drug: 18F-AV-1451Subjects with history of recent subacute Traumatic Brain Injury (TBI) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451 2 to 6 weeks following injury. They will return for a follow-up injection approximately 6 months following injury. |
| Control | Experimental | Drug: 18F-AV-1451Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- TBI Subjects
- Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084
- History of having sustained a TBI < 6 weeks prior to enrollment
- Can tolerate PET and MRI scan procedures
- Control Subjects
Key exclusion criteria (11 listed)
- Have behavior dysfunction that is likely to interfere with imaging
- Are claustrophobic or otherwise unable to tolerate the imaging procedure
- Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG
- A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
- Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
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 |
|---|---|---|
| 18F-AV-1451Also: [F-18]T807 | Drug | Control, TBI Subjects |
Primary outcome
TBI Biomarker Analysis
Time frame: 75-105 minutes postinjection
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Relationship Between Clinical Presentation and Tau Deposition (MMSE)
Time frame: 75-105 minutes postinjection
The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
Change in tau deposition over time
Time frame: 6 months
Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.
Relationship Between Clinical Presentation and Tau Deposition (BIS-11)
Time frame: 75-105 minutes postinjection
The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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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.
Chief Medical Officer study chair
Avid Radiopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-AV-1451 in people with Traumatic Brain Injury, run by Avid Radiopharmaceuticals 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 9 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Feb 2016. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
TBI Biomarker Analysis (time frame: 75-105 minutes postinjection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2016.