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Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Primary Purpose

Brain Fibrillarab Levels

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
[18F] Flutemetamol
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Fibrillarab Levels focused on measuring Amyloid, PET-Positron Emission Tomography, SUVR-Standard uptake value ratios

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
  • The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
  • The subject's general health is adequate to undergo the study procedures.

Exclusion Criteria:

  • The subject has a contraindication for PET.
  • The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
  • The subject is unable to tolerate or cooperate with study procedures.

Sites / Locations

  • GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F] Flutemetamol

Arm Description

Outcomes

Primary Outcome Measures

The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

Secondary Outcome Measures

Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.
A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants). Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.
Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.
Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.

Full Information

First Posted
June 21, 2010
Last Updated
November 8, 2013
Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Covance
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1. Study Identification

Unique Protocol Identification Number
NCT01165554
Brief Title
Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels
Official Title
A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Covance

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Fibrillarab Levels
Keywords
Amyloid, PET-Positron Emission Tomography, SUVR-Standard uptake value ratios

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[18F] Flutemetamol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F] Flutemetamol
Other Intervention Name(s)
AH110690
Intervention Description
Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
Primary Outcome Measure Information:
Title
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
Description
A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants). Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.
Time Frame
Post flutemetamol administration.
Secondary Outcome Measure Information:
Title
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.
Description
A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants). Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.
Time Frame
Post Flutemetamol administrations
Title
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.
Description
Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.
Time Frame
Post flutemetamol administration.
Title
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.
Description
Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.
Time Frame
Post flutemetamol administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator. The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. The subject's general health is adequate to undergo the study procedures. Exclusion Criteria: The subject has a contraindication for PET. The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients. The subject is unable to tolerate or cooperate with study procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sherwin, MD, PhD
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31727169
Citation
Thal DR, Ronisz A, Tousseyn T, Rijal Upadhaya A, Balakrishnan K, Vandenberghe R, Vandenbulcke M, von Arnim CAF, Otto M, Beach TG, Lilja J, Heurling K, Chakrabarty A, Ismail A, Buckley C, Smith APL, Kumar S, Farrar G, Walter J. Different aspects of Alzheimer's disease-related amyloid beta-peptide pathology and their relationship to amyloid positron emission tomography imaging and dementia. Acta Neuropathol Commun. 2019 Nov 14;7(1):178. doi: 10.1186/s40478-019-0837-9. Erratum In: Acta Neuropathol Commun. 2020 Aug 3;8(1):121.
Results Reference
derived
PubMed Identifier
30123935
Citation
Thal DR, Beach TG, Zanette M, Lilja J, Heurling K, Chakrabarty A, Ismail A, Farrar G, Buckley C, Smith APL. Estimation of amyloid distribution by [18F]flutemetamol PET predicts the neuropathological phase of amyloid beta-protein deposition. Acta Neuropathol. 2018 Oct;136(4):557-567. doi: 10.1007/s00401-018-1897-9. Epub 2018 Aug 19.
Results Reference
derived
PubMed Identifier
27955679
Citation
Ikonomovic MD, Buckley CJ, Heurling K, Sherwin P, Jones PA, Zanette M, Mathis CA, Klunk WE, Chakrabarty A, Ironside J, Ismail A, Smith C, Thal DR, Beach TG, Farrar G, Smith AP. Post-mortem histopathology underlying beta-amyloid PET imaging following flutemetamol F 18 injection. Acta Neuropathol Commun. 2016 Dec 12;4(1):130. doi: 10.1186/s40478-016-0399-z.
Results Reference
derived

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Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

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