Discovering FFC-MRI Biomarkers of Alzheimer Disease
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FFC-MRI scan
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with probable Alzheimer's disease, based upon cognitive testing (MMSE) and SPECT imaging.
- Controls will be participants without known cognitive impairment or Alzheimer's disease.
- Subjects capable of giving informed consent.
- Age 21 and above
Exclusion Criteria:
- MRI-incompatible condition detected in the MR screening sheet such as some metallic implanted devices (see MR screening sheet in the project files).
- Claustrophobia
- Waist circumference larger than 102 cm, due to the limited bore size of the scanner.
- Restrictions to mobility such that patients are unable to be positioned in scanner by trained research radiographer e.g. severe kyphosis
- Cognitive impairment of sufficient severity that the participant does not have capacity to give informed consent
- Pregnancy
- Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
- Dementia of sufficient severity that the participant cannot give informed consent
Sites / Locations
- Biomedical Physics Building, Foresterhill Health Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alzheimer's patients
Control
Arm Description
Patient diagnosed with early onset Alzheimer's disease.
Healthy volunteers that do not have Alzheimer's disease.
Outcomes
Primary Outcome Measures
Primary Outcome
The FFC-MRI T1 maps of patients and controls, with SPECT findings for validation. The outcome used for the primary research question will be the statistical significance in the difference of image contrast between the control group and the patient group. The presence of AD in the patient group will be estimated using the current clinical standard, cognitive testing with MoCA) or MMSE and blood flow SPECT CT imaging. If the participant has recently had an MRI scan using 3T MRI, we will ask for permission from the participant to access these images and use them for comparison.
The level of significance of the differences will be derived using the statistical test most adapted to the contrast, depending on the distribution profile across the samples. No previous data exist to guide our choice.
Secondary Outcome Measures
Secondary Outcome
Variations in the FFC-MRI biomarkers obtained for the T1 maps. The outcome of interest to fulfil our secondary objective is the estimation of the distribution of the contrast identified as potential biomarkers. This will allow us to estimate the sample size for further validation studies.
Full Information
NCT ID
NCT05220150
First Posted
December 2, 2020
Last Updated
February 1, 2022
Sponsor
University of Aberdeen
1. Study Identification
Unique Protocol Identification Number
NCT05220150
Brief Title
Discovering FFC-MRI Biomarkers of Alzheimer Disease
Official Title
Non-invasive In-vivo Characterisation of Alzheimer's Disease Using Fast-field Cycling Magnetic Resonance Imaging (FFC MRI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment and poor scan image quality
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fast Field-Cycling MRI (FFC MRI) is a new scanning technology being developed at the University of Aberdeen. Previous pilot studies by the team on osteoarthritis, breast cancer, musculoskeletal cancer, liver fibrosis, thrombosis and muscle damage have demonstrated that FFC MRI provides useful information for clinical diagnostics in a variety of pathologies.
The aim of this study is to ascertain if brain imaging with FFC MRI yields any useful information in the diagnosis and evaluation of Alzheimer's disease.
Detailed Description
Alzheimer's disease (AD) patients and appropriate controls will be identified by consultants working with the patient group.
Potential participants will be approached by letter by their clinician. The purpose of this study will be explained to them and they will be asked for signed informed consent.
Communication between the clinical team and FFC-MRI research team will ensure that any appointment for FFC-MRI is made at a time that is convenient for the patient and clinical team.
The aim is to recruit 25 individuals with AD and 25 age matched controls.
FFC-MRI images will be acquired on dedicated equipment specifically built for the purpose of imaging human volunteers and patients. Where clinically appropriate patents will undergo other imaging procedures as part of their normal NHS care.
FFC-MRI will be compared standard clinical care data to identify regions of interest for quantitative analysis of FFC MRI data.
Anonymous personal information will be collected from the NHS patient records for stratification of the results (such as age, sex or relevant examination results)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open labelled feasibility study with a control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alzheimer's patients
Arm Type
Experimental
Arm Description
Patient diagnosed with early onset Alzheimer's disease.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Healthy volunteers that do not have Alzheimer's disease.
Intervention Type
Device
Intervention Name(s)
FFC-MRI scan
Intervention Description
Undergo one FFC-MRI scan.
Primary Outcome Measure Information:
Title
Primary Outcome
Description
The FFC-MRI T1 maps of patients and controls, with SPECT findings for validation. The outcome used for the primary research question will be the statistical significance in the difference of image contrast between the control group and the patient group. The presence of AD in the patient group will be estimated using the current clinical standard, cognitive testing with MoCA) or MMSE and blood flow SPECT CT imaging. If the participant has recently had an MRI scan using 3T MRI, we will ask for permission from the participant to access these images and use them for comparison.
The level of significance of the differences will be derived using the statistical test most adapted to the contrast, depending on the distribution profile across the samples. No previous data exist to guide our choice.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
Variations in the FFC-MRI biomarkers obtained for the T1 maps. The outcome of interest to fulfil our secondary objective is the estimation of the distribution of the contrast identified as potential biomarkers. This will allow us to estimate the sample size for further validation studies.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with probable Alzheimer's disease, based upon cognitive testing (MMSE) and SPECT imaging.
Controls will be participants without known cognitive impairment or Alzheimer's disease.
Subjects capable of giving informed consent.
Age 21 and above
Exclusion Criteria:
MRI-incompatible condition detected in the MR screening sheet such as some metallic implanted devices (see MR screening sheet in the project files).
Claustrophobia
Waist circumference larger than 102 cm, due to the limited bore size of the scanner.
Restrictions to mobility such that patients are unable to be positioned in scanner by trained research radiographer e.g. severe kyphosis
Cognitive impairment of sufficient severity that the participant does not have capacity to give informed consent
Pregnancy
Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
Dementia of sufficient severity that the participant cannot give informed consent
Facility Information:
Facility Name
Biomedical Physics Building, Foresterhill Health Campus
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Discovering FFC-MRI Biomarkers of Alzheimer Disease
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