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Tau Imaging in Professional Fighters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278354
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 28, 2014
First Posted Date  ICMJE October 30, 2014
Results First Submitted Date  ICMJE July 16, 2020
Results First Posted Date  ICMJE September 10, 2020
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE February 18, 2015
Actual Primary Completion Date February 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2020)
  • 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.
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
18F-AV-1451 Uptake [ Time Frame: 75-105 minutes post injection ]
Standard Uptake Value Ratios (SUVRs) by subject enrollment group (active/retired and cognitive impaired/normal) will be compared to detect differences across the enrollment groups.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tau Imaging in Professional Fighters
Official Title  ICMJE 18F-AV-1451 PET Imaging in Professional Fighters
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Flortaucipir F18
    IV injection, 370 megabecquerel (MBq) (10 mCi)
    Other Names:
    • [F-18]T807
    • 18F-AV-1451
    • LY3191748
    • Tauvid
  • Procedure: Brain PET scan
    positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Study Arms  ICMJE
  • Experimental: Active Professional Fighters
    Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
    Interventions:
    • Drug: Flortaucipir F18
    • Procedure: Brain PET scan
  • Experimental: Retired Professional Fighters
    Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
    Interventions:
    • Drug: Flortaucipir F18
    • Procedure: Brain PET scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2020)
35
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2014)
30
Actual Study Completion Date  ICMJE February 3, 2017
Actual Primary Completion Date February 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02278354
Other Study ID Numbers  ICMJE 18F-AV-1451-A11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Avid Radiopharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avid Radiopharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE Not Provided
PRS Account Avid Radiopharmaceuticals
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP