Clinical trial NCT07012993: Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting Amyloid Tracer Uptake
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Healthy Volunteer
Alzheimer&#39;s Disease, Mild Cognitive Impairment, Other Forms of Dementia
Lead sponsor: Nuclear Imaging Institute
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate an investigational ultralow dose 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 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Ability to provide informed consent and comply with study procedures.
3. For female participants:

   * Must not be pregnant or breastfeeding.
   * Negative pregnancy test required for women of childbearing potential.

Exclusion Criteria:

1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
2. More than four prior enrollments in this study.
3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan
4. Pregnant or breastfeeding individuals (negative pregnancy test required)
5. Inability to provide informed consent
6. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Primary outcomes:
measure: Signal-to-Noise Ratio (SNR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Contrast-to-Noise Ratio (CNR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Coefficient of Variation (COV)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Spatial Resolution (Full Width at Half Maximum - FWHM)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Target-to-Background Ratio (TBR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Qualitative Image Quality Score (Likert Scale)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Inter-reader Agreement (Weighted Kappa Statistics)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Nuclear Imaging Institute
state: New Jersey
Study officials:
References: