18F-AV-1451 PET Imaging in TBI

February 4, 2016 updated by: Avid Radiopharmaceuticals

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • NIH Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBI Biomarker Analysis
Time Frame: 75-105 minutes postinjection
18F-AV-1451 uptake will be compared in subjects with TBI and controls.
75-105 minutes postinjection
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).
75-105 minutes postinjection
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.
6 months
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)
75-105 minutes postinjection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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