Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 7:37 PM
Study NCT ID:
NCT07012993
Status:
RECRUITING
Last Update Posted:
2025-06-10
First Post:
2025-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol
Sponsor:
Akiva Mintz
Organization:
Study Overview
Official Title:
Evaluation of Ultralow Dose PET Imaging for Detecting Amyloid Tracer Uptake
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: