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18F-AV-1451 PET Imaging in TBI

Primary Purpose

Traumatic Brain Injury

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-AV-1451
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

TBI Subjects

Inclusion Criteria:

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
  • No significant history of cognitive impairment
  • No prior history of TBI
  • Can tolerate PET and MRI scan procedures

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • NIH Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TBI Subjects

Control

Arm Description

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.

Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451.

Outcomes

Primary Outcome Measures

TBI Biomarker Analysis
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Relationship Between Clinical Presentation and Tau Deposition (MMSE)
The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
Change in tau deposition over time
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)
The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)

Secondary Outcome Measures

Full Information

First Posted
July 28, 2015
Last Updated
February 4, 2016
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02512029
Brief Title
18F-AV-1451 PET Imaging in TBI
Official Title
18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TBI Subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of 18F-AV-1451.
Intervention Type
Drug
Intervention Name(s)
18F-AV-1451
Other Intervention Name(s)
[F-18]T807
Primary Outcome Measure Information:
Title
TBI Biomarker Analysis
Description
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Time Frame
75-105 minutes postinjection
Title
Relationship Between Clinical Presentation and Tau Deposition (MMSE)
Description
The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
Time Frame
75-105 minutes postinjection
Title
Change in tau deposition over time
Description
Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.
Time Frame
6 months
Title
Relationship Between Clinical Presentation and Tau Deposition (BIS-11)
Description
The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)
Time Frame
75-105 minutes postinjection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
TBI Subjects Inclusion Criteria: 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 No significant history of cognitive impairment No prior history of TBI Can tolerate PET and MRI scan procedures Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
NIH Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

18F-AV-1451 PET Imaging in TBI

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