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History of Changes for Study: NCT02278354
Tau Imaging in Professional Fighters
Latest version (submitted August 21, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 28, 2014 None (earliest Version on record)
2 January 7, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 May 27, 2016 Study Status
4 April 13, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Results Submission Events
5 August 21, 2020 Study Status, Arms and Interventions, Oversight, Document Section, Results, Outcome Measures, Study Design and Study Description
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Study NCT02278354
Submitted Date:  October 28, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 18F-AV-1451-A11
Brief Title: Tau Imaging in Professional Fighters
Official Title: 18F-AV-1451 PET Imaging in Professional Fighters
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2014
Overall Status: Not yet recruiting
Study Start: November 2014
Primary Completion: November 2015 [Anticipated]
Study Completion: November 2015 [Anticipated]
First Submitted: October 28, 2014
First Submitted that
Met QC Criteria:
October 28, 2014
First Posted: October 30, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 28, 2014
Last Update Posted: October 30, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Avid Radiopharmaceuticals
Responsible Party: Sponsor
Collaborators: The Cleveland Clinic
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive 18F-AV-1451 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:
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active Professional Fighters
Active professional fighters (with and without cognitive impairment) will receive a single intravenous (IV) bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of 18F-AV-1451.
Drug: 18F-AV-1451
Other Names:
  • [F-18]T807
Experimental: Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) will receive a single IV bolus injection of 370 MBq (10mCi) of 18F-AV-1451.
Drug: 18F-AV-1451
Other Names:
  • [F-18]T807
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Avid Clinical Operations
Telephone: 215-298-0700
Email: clinicaloperations@avidrp.com
Locations: United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Contact:Contact: Triny Cooper 702-483-6013
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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