Tau Imaging in Professional Fighters

August 21, 2020 updated by: Avid Radiopharmaceuticals

18F-AV-1451 PET Imaging in Professional Fighters

Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Cleveland Clinic Lou Ruvo Center for Brain Health

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

All Subjects

  • Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
  • Can tolerate Positron Emission Tomography (PET) scan procedures
  • Have the ability to provide informed consent

Subjects with cognitive impairment

  • Have subjective cognitive complaints or objective decline or impairment as determined by the investigator

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 electrocardiogram
  • 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
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
  • Have current drug or alcohol dependence or alcohol dependence within the past 2 years

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Experimental: Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • 18F-AV-1451
  • [F-18]T807
  • LY3191748
  • Tauvid
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Time Frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
baseline scan
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Time Frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
baseline scan
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Time Frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
baseline scan
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Time Frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
baseline scan

Collaborators and Investigators

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

Sponsor

Avid Radiopharmaceuticals

Collaborators

The Cleveland Clinic

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 (Actual)

February 18, 2015

Primary Completion (Actual)

February 3, 2017

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 30, 2014

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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