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18F-AV-1451 PET Imaging in TBI

Sponsor
Avid Radiopharmaceuticals (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02512029
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
18
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: TBI Subjects

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.

Drug: 18F-AV-1451
Other Names:
  • [F-18]T807

    		•
    Experimental: Control

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

    Drug: 18F-AV-1451
    Other Names:
  • [F-18]T807

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TBI Biomarker Analysis [75-105 minutes postinjection]

      18F-AV-1451 uptake will be compared in subjects with TBI and controls.

    2. Relationship Between Clinical Presentation and Tau Deposition (MMSE) [75-105 minutes postinjection]

      The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).

    3. Change in tau deposition over time [6 months]

      Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.

    4. Relationship Between Clinical Presentation and Tau Deposition (BIS-11) [75-105 minutes postinjection]

      The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NIH Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • Avid Radiopharmaceuticals

    Investigators

    • Study Chair: Chief Medical Officer, Avid Radiopharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Avid Radiopharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02512029
    Other Study ID Numbers:
    • 18F-AV-1451-A12
    First Posted:
    Jul 30, 2015
    Last Update Posted:
    Feb 5, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic

    Study Results

    No Results Posted as of Feb 5, 2016