Ultralow-dose amyloid PET with 18F‑Florbetapir or 18F‑Flutemetamol
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting Amyloid Tracer Uptake
Run by Nuclear Imaging Institute · NCT07012993 · Data updated 2026-11-12
This trial will try using a very small amount of an amyloid PET tracer with a high-sensitivity PET scanner to see if clear brain images can be made for people with Alzheimer’s, mild cognitive impairment, other dementias, and healthy volunteers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Englewood, New Jersey) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | June 30, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07012993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with Alzheimer disease, mild cognitive impairment, other dementias, or healthy volunteers who can give informed consent, are not pregnant or breastfeeding, and can tolerate PET scanning are eligible.
✕Probably not a fit
People who have exceeded allowable research radiation exposure, are pregnant or breastfeeding, cannot tolerate PET scanning due to claustrophobia or pain, or cannot consent may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will receive a much smaller than usual injection of an FDA‑approved amyloid tracer (18F‑Florbetapir or 18F‑Flutemetamol) and be imaged on a high-sensitivity PET scanner for up to three hours. Investigators will vary timing, scan duration, and image reconstruction methods to determine whether image quality can be maintained while reducing radiation dose by roughly 10–100 fold. The study enrolls adults with Alzheimer disease, mild cognitive impairment, other dementias, and healthy volunteers to compare tracer uptake and image clarity across groups. The primary aim is to develop protocols that allow diagnostically useful amyloid images at substantially lower radiation exposure.
Why it matters
Potential benefit: If successful, the technique could enable much lower‑radiation amyloid PET scans that are safer and could be used more frequently for diagnosis and monitoring.
How similar studies have gone: Prior pilot work and studies using high-sensitivity and total‑body PET systems have shown promise for reducing dose, but the extreme 10–100× ultralow dosing tested here remains novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Nuclear Imaging Institute
Englewood, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Barbara Blanchfield
- Email: bblanchfield@nii.org
- Phone: 973-255-4955
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.