Tau Imaging in Professional Fighters
18F-AV-1451 PET Imaging in Professional Fighters
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
October 30, 2014
CompletedStudy Start
First participant enrolled
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2017
CompletedResults Posted
Study results publicly available
September 10, 2020
CompletedSeptember 10, 2020
August 1, 2020
2 years
October 28, 2014
July 16, 2020
August 21, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
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
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
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
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
baseline scan
Study Arms (2)
Active Professional Fighters
EXPERIMENTALActive professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Retired Professional Fighters
EXPERIMENTALRetired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Interventions
IV injection, 370 megabecquerel (MBq) (10 mCi)
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avid Radiopharmaceuticalslead
- The Cleveland Cliniccollaborator
Study Sites (1)
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Avid Radiopharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2014
First Posted
October 30, 2014
Study Start
February 18, 2015
Primary Completion
February 3, 2017
Study Completion
February 3, 2017
Last Updated
September 10, 2020
Results First Posted
September 10, 2020
Record last verified: 2020-08