18F-AV-1451 High Resolution Autopsy Study

May 22, 2025 updated by: Avid Radiopharmaceuticals

A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
    • California
      • San Francisco, California, United States, 94121
        • University of California, San Francisco

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 flortaucipir F18.
Drug: Flortaucipir F18
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of flortaucipir.
Other Names:
  • 18F-AV-1451
  • [F-18]T807

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan
Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region
Time Frame: autopsy within 6 months of scan
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
autopsy within 6 months of scan

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avid Radiopharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Avid Radiopharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18F-AV-1451-A13

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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