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

May 6, 2022 updated by: University Hospitals Cleveland Medical Center

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:

  1. 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.
  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?
  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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

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
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital Case Medical Center

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

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PET/CT vs. PET/MRI

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.
Device: PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
within one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: within one year
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?
within one year
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;
Time Frame: within one year
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)
within one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: within one year
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.
within one year

Collaborators and Investigators

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

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: James K O'Donnell, MD, Unviversity Hospitals Case Medical Center

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)

October 1, 2013

Primary Completion (Actual)

November 9, 2016

Study Completion (Actual)

November 9, 2016

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-12-13

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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