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18F-AV-1451 High Resolution Autopsy Study

Sponsor
Avid Radiopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02350634
Collaborator
(none)
3
Enrollment
2
Locations
1
Arm
35.5
Duration (Months)
1.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
May 18, 2018
Actual Study Completion Date :
May 18, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autopsy Cohort

End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of 18F-AV-1451.

Drug: 18F-AV-1451
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
Other Names:
  • [F-18]T807

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relationship of 18F-AV-1451 scan and pathology [autopsy within 6 months of scan]

      Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Projected life expectancy ≤ 6 months
    Exclusion Criteria:

    • Primary brain tumor, known metastases to the brain, central nervous system lymphoma

    • Major, focal structural brain lesion

    • Aggressively being treated with life sustaining measures

    • Clinically significant infectious disease

    • History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation

    • Have received or participated in a trial with investigational medications in the past 30 days

    • Females of childbearing potential who are pregnant or not using adequate contraception

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner Alzheimer's Institute Phoenix Arizona United States 85006
    2 University of California, San Francisco San Francisco California United States 94121

    Sponsors and Collaborators

    • Avid Radiopharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Avid Radiopharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02350634
    Other Study ID Numbers:
    • 18F-AV-1451-A13
    First Posted:
    Jan 30, 2015
    Last Update Posted:
    Oct 24, 2018
    Last Verified:
    Oct 1, 2018
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Oct 24, 2018