Ultralow-dose 18F-FDG PET imaging with a high-sensitivity scanner
Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDG Uptake
This will test whether an ultralow-dose 18F-FDG PET scan using a high-sensitivity scanner can detect and monitor cancer in people with and without cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT06956391 on ClinicalTrials.gov |
What this trial studies
The study uses a very small amount of the standard 18F-FDG tracer (under 1/20th of the usual dose) and a new high-sensitivity PET scanner to acquire images over periods up to three hours. Investigators will vary injection-to-scan timing, scan duration, and image reconstruction methods to optimize image quality at dramatically reduced radiation levels. Approximately 200 adults, including healthy volunteers and people with cancer, will be imaged at the Nuclear Imaging Institute. The primary goal is to determine whether diagnostically useful images can be produced with a 10- to 100-fold reduction in radiation dose compared with current clinical practice.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent, are not pregnant or breastfeeding, can tolerate prolonged PET imaging, and have not exceeded regulatory limits for research-related radiation exposure are eligible, including both healthy volunteers and people with cancer.
Not a fit: People who are pregnant or breastfeeding, unable to tolerate long scans (for example due to severe claustrophobia or pain), or who have already reached regulatory radiation exposure limits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide much safer PET imaging with substantially lower radiation exposure, allowing more frequent screening and monitoring.
How similar studies have performed: Prior pilot studies of high-sensitivity PET and low-dose protocols have shown promising results, but achieving a 10- to 100-fold dose reduction while maintaining diagnostic quality remains largely experimental.
Eligibility criteria
Show full inclusion / exclusion 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. Medication \& Prior Treatment Exclusions 5. Pregnant or breastfeeding individuals (negative pregnancy test required) 6. Inability to provide informed consent 7. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
Where this trial is running
Englewood, New Jersey
- Nuclear Imaging Institute — Englewood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Barbara Blanchfield
- Email: bblanchfield@nii.org
- Phone: 973-255-4955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.