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Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid

Primary Purpose

Dementia, Alzheimer Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Dementia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition,
  • Patients equal to or greater than 21 years old,
  • Signed informed consent by patient or legal guardian,
  • Physically capable to cooperate.

Exclusion Criteria:

  • Subjects who do not meet the above mentioned inclusion criteria,
  • Subjects unwilling or unable to sign the informed consent form,
  • Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study,
  • Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices),
  • History of adverse events related to a previous MR or PET/CT,
  • Pregnant women,
  • Minors.

Sites / Locations

  • University Hospital Case Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET/CT vs. PET/MRI

Arm Description

Patients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined. Patients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1.

Outcomes

Primary Outcome Measures

To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.

Secondary Outcome Measures

To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.
2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;
3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid (Philips Research, Hamburg)

Full Information

First Posted
May 8, 2014
Last Updated
May 6, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02343757
Brief Title
Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
Official Title
Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Not enough patient enrollment
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The early detection of a preclinical AD or early stage of AD with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural MR sequences and newly FDA-approved biomarker for amyloid PET imaging, all these two techniques with their strengths in one machine. Specific Aims and Hypotheses can be summarized as follows: To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity? To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/CT vs. PET/MRI
Arm Type
Other
Arm Description
Patients will be included if presenting with the clinical suspicious of AD, Mild Cognitive Impairment (MCI) or other cognitive impairment to be further determined. Patients will undergo two doubles scans in two steps with a maximum of 2 week between both: the first step will be one day double scan with FDG imaged by PET-CT and PET-MRI; and the second step will be one day double scan with 18F-florbetapir imaged by PET-CT and PET-MRI at a different timepoints as shown in figure 1.
Intervention Type
Device
Intervention Name(s)
PET/MRI
Primary Outcome Measure Information:
Title
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
Description
To assess image quality and diagnostic performance of 18F-florbetapir (AMYVID) PET/MRI, including direct comparison to corresponding PET/CT images of the same patients.
Time Frame
within one year
Secondary Outcome Measure Information:
Title
To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone.
Description
2. To evaluate the incremental value of using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus FDG alone. Does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by FDG as well as with clinical severity?
Time Frame
within one year
Title
To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application;
Description
3. To determine plaque burden quantitatively with 18F-florbetapir (AMYVID) in PET (form PET/CT and from PET/MR) using novel software developed specifically for these brain application; Computer-Aid Diagnosis for Dementia for amyloid imaging - CAD4D-amyloid (Philips Research, Hamburg)
Time Frame
within one year
Other Pre-specified Outcome Measures:
Title
Measurement of Effect (ability of 18F-florbetapir (AMYVID) PET/MRI to assess the diagnosis of a patient, compared to both PET/CT and the diagnosis from the clinical record)
Description
The main effect that will be evaluated in this study is the ability of 18F-florbetapir (AMYVID) PET/MRI to assess the diagnosis of a patient, compared to both PET/CT and the diagnosis from the clinical record. Another effect that will be evaluated is if there is an added value when using 18F-florbetapir (AMYVID) in addition to 2-[F-18]-fluoro-2 deoxy-D-glucose (FDG) versus using only FDG in the evaluation of cognitive impairment patients.
Time Frame
within one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with suspected AD, MCI and other cognitive impairment will be referred by their neurologist to have a clinical ordered FDG-PET/CT and clinically indicated AMYVID in addition, Patients equal to or greater than 21 years old, Signed informed consent by patient or legal guardian, Physically capable to cooperate. Exclusion Criteria: Subjects who do not meet the above mentioned inclusion criteria, Subjects unwilling or unable to sign the informed consent form, Subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study, Subjects unable to undergo MR scanning due to exclusion via UHCMC MR restrictions (e.g. certain implanted metallic or electronic devices), History of adverse events related to a previous MR or PET/CT, Pregnant women, Minors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James K O'Donnell, MD
Organizational Affiliation
Unviversity Hospitals Case Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Alzheimer's Disease Imaging With PET/MRI - Beta-amyloid

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