Alzheimer Disease, Dementia, Healthy Volunteers, Mild Cognitive Impairment
Conditions
Keywords
Amyloid, PET, ultralow dose, PET/CT
Brief summary
The goal of this clinical trial is to evaluate an investigational ultralow dose Positron Emission Tomography (PET) imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of dementia detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called Fluorine-18 (18F)-Florbetapir or 18F-Flutemetamol and be imaged on a new type of high-sensitivity PET scanner for up to 3 hours
Detailed description
This research study aims to evaluate an investigational ultralow dose PET imaging technique for Alzheimer's disease, mild cognitive impairment, other forms of dementia detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the U.S. Food and Drug Administration (FDA) for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracers are FDA-approved for detecting amyloid plaque that is found in Alzheimer's Disease at standard doses, but at a much higher dose than is being investigated in this protocol. 18F-Florbetapir and 18F-Flutemetamol are often found to be taken up at higher levels in Alzheimer's disease, mild cognitive impairment, other forms of dementia. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Alzheimer's disease, mild cognitive impairment, other forms of dementia. Investigators will enroll individuals with and without Alzheimer's disease, mild cognitive impairment, other forms of dementia to evaluate how ultralow dose PET imaging detects radiotracer uptake in different types of tissue. Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.
Interventions
DRUG18F-Florbetapir or 18F-Flutemetamol
Participants will be injected with 18F-Florbetapir or 18F-Flutemetamol and imaged for up to 3 hours on a PET scanner
Sponsors
Akiva Mintz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
Inclusion criteria
Age ≥18 years; Ability to provide informed consent and comply with study procedures; For female participants: Must not be pregnant or breastfeeding; Negative pregnancy test required for women of childbearing potential.
Exclusion criteria
Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert \[mSv\] total); More than four prior enrollments in this study; Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan; Pregnant or breastfeeding individuals (negative pregnancy test required); Inability to provide informed consent; Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and artificial intelligence (AI)-enhanced image reconstructions. Unit of Measure: SNR (unitless, numeric ratio) |
| Contrast-to-Noise Ratio (CNR) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: CNR (unitless, numeric ratio) |
| Coefficient of Variation (COV) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Percentage (%) |
| Spatial Resolution (Full Width at Half Maximum - FWHM) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Millimeters (mm) |
| Target-to-Background Ratio (TBR) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Ratio (unitless numeric ratio) |
| Qualitative Image Quality Score (Likert Scale) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best) |
| Inter-reader Agreement (Weighted Kappa Statistics) | Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. | Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement) |
Countries
United States
Contacts
CONTACTBarbara Blanchfield
Outcome results
None listed