Ultralow Dose PET Imaging of 18F-Florbetapir, 18F-Flutemetamol

NCT ID: NCT07012993

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2030-06-30

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.

Conditions

Healthy Volunteer; Alzheimer's Disease, Mild Cognitive Impairment, Other Forms of Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultralow dose imaging group

Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Group Type: OTHER

18F-Florbetapir or 18F-Flutemetamol

Intervention Type: DRUG

Participants will be injected with 18F-Florbetapir or 18F-Flutemetamol and imaged for up to 3 hours on a PET scanner

Interventions

18F-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

Intervention Type: DRUG

Other Intervention Names

CT scan; PET scan; blood collection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akiva Mintz

OTHER

Sponsor Role: lead

Responsible Party

Akiva Mintz

Executive Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nuclear Imaging Institute

Englewood, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barbara Blanchfield

Role: CONTACT

bblanchfield@nii.org

973-255-4955

Facility Contacts

Barbara Blanchfield

Role: primary

973-255-4955

Other Identifiers

NII-0005-amyloid

Identifier Type: -

Identifier Source: org_study_id